Microsoft word - malhotra cv.doc

RANJAN P. MALHOTRA, M.D., F.A.C.S.
Clinical Instructor of Ophthalmology
Washington University School of Medicine
St. Louis, Missouri
Primary Office Address:

Secondary Office Address: 965 Mattox Drive

Primary Surgical Address: St. Louis Eye Surgery and Laser Center
Date of Birth:
Place of Birth:

EDUCATION:
Fellowship 1999 – 2000
Cornea, Refractive Surgery, and External Disease
Residency
University of Texas Southwestern Medical Center Parkland Memorial Hospital, Dallas, Texas
Internship
Bachelor of Arts in Biology with Distinction, 1993 Alumni Day Research Award, Dallas, Texas LICENSURE AND CERTIFICATION:

Customvue Wavefront Certification VISX 2003 - Present LASIK Certification
RESEARCH:
Involved in Phase 2,3 and 4 Clinical Trials for Dry Eye, Allergy, Blepharitis,
Conjunctivitis, Cataract surgery and Glaucoma

PUBLICATIONS:
Malhotra, R., Ackerman, S., Gearinger, L., Morris, T., Allaire, C.: The Safety of
Besifloxacin Ophthalmoic Suspension 0.6% Used Three Times Daily for 7 Days
in the Treatment of Bacterial Conjunctivitis. Springer On Line First. 2013.
10.1007/s40268-013-0029-1.

Malhotra, RP. Wolf TC, Chodosh J. “Diffuse Lamellar Keratitis after Traumatic Corneal
Abrasion Postoperative LASIK Patients.” Published in departmental publication for Dean A. McGee Eye Institute, June 10, 2000. Malhotra RP. Bowman RW. “Corneal Sensation after Laser Intrastromal Keratomileusis (LASIK)” Published in departmental publication for Southwestern Medical School, *Alumni Day Research Award, June 1999. Malhotra RP. Bowman RW. “Retreatment after Excimer Laser Photorefractive Keratectomy (PRK) and Laser Intrastromal Keratomileusis (LASIK)” Published and presented as paper at American Society of Cataract and Refractive Surgeons, Seattle WA April 1999. Malhotra RP. Park S. “The Effects of Vitrectomy and Membrane Peeling on Metmorphopsia and Visual Acuity in Patients with Macular Pucker” Published in a departmental publication for Southwestern Medical School, Malhotra RP. Jaffe. Tauber J. “Contact Lens and Spectacle Use Before and After Photorefractive Keratectomy” Accepted for publication and poster presentation for Contact Lens Association of Ophthalmologists Conference, Las Vegas NV, Malhotra RP. Nyquist-Battle C. Dreyfus LA. Morris SJ. “Escherichia coli Heat-stable Enterotoxin B (Stb) Opens ad G-protein Operated Calcium Channel in the Myocyte Plasma Membrane” Student paper presentation at University of Missouri-Kansas City School of Medicine Research Days, April 1994. Morris SJ Chronwall B. Malhotra RP Beatty D. “Simultaneous Kinetic Imaging of Intracellular Calcium and pH in Single Melanotropes” Student poster presentation at University of Missouri-Kansas City School of Medicine Research Days,

PROFESSIONAL ORGANIZATIONS:

American Association of Physicians of Indian Origin (AAPI) American Society of Cataract and Refractive Surgeons (ASCRS) Indian Medical Council of Greater St. Louis Missouri Ophthalmologic Society of Eye Physicians and Surgeons (MOSEPS) Missouri State Medial Association (MSMA)
LEADERSHIP AND EMPLOYMENT:

Ophthalmology Associates/Cornea & Laser Vision Institute, Missouri Ophthalmologic Society of Eye Physicians and Surgeons Board of Directors, St. Louis Representative 2003 – 2007 Indian Medical Council of Greater St. Louis Board Member 2003 - Present Indian Association of St. Louis Board Member Denton State School for Mentally Impaired Adults, Medical Student Advisory Council Representative Clinical Research Study Participation
Ophthalmology Associates
Ranjan P. Malhotra, M.D.,F.A.C.S.
Gregg J. Berdy, M.D., F.A.C.S.
Robert C. Brusatti, O.D.
Alcon – Protocol C-00-13 (2000)
A Comparative Study of the Prophylactic Use of Olopatadine 0.1% Ophthalmic Solution Versus Placebo,
in Patients with Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis
Senju - Protocol TIMLA-301-PC-1 (2001)
A double-masked, randomized, parallel study of the safety and efficacy of Timolol-LA in patients with
ocular hypertension or open-angle glaucoma
Allergan - Protocol l98027-003-00 (2001)
A Multi-Center, Randomized, Double-Masked, Parallel Group Study Evaluating the Efficacy and Safety of
Epinastine Hydrochloride 0.05% Ophthalmic Solution Compared to Vehicle of Epinastine or to
Levocabastine 0.05% Ophthalmic Suspension Used Twice Daily for 8 Weeks in an Environmental Study in
Adult and Pediatric Patients with seasonal Allergic Conjunctivitis
Inspire - Protocol 03-104 (2002)
A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple
Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Subjects with Dry eye Disease
Allergan - Protocol l95263-003-00 (2002)
A Multi-Center, Parallel, Randomized, Double-Masked, Vehicle Controlled, Dose-Ranging Study to
Evaluate the Safety, tolerability, and Efficacy of Testosterone 0.01T, 0.1%, and 0.3% Ophthalmic Solutions
Administered Twice Daily for 16 weeks in Patients with Keratoconjunctivitis Sicca (KCS)
Ciba Vision (Novartis) - Protocol P-215-C-001
Ham Comfort Drops Registration Trial
Ciba Vision - Protocol 019-C-004
SEE3 Monthly Extended Wear Safety & Efficacy Study

Ciba Vision - Protocol P-019-C-023 (2003)
Focus Night & Day Post-approval Evaluation (contact lens study)

Medennium - Protocol # Plug-00-001 (2002)
A Prospective, Randomized, Open-Label Clinical Evaluation of the Efficacy, Safety and Substantial
Equivalence of the Medennium Inc. SmartPlug vs. the Oasis Soft Plug in the Treatment of Dry Eye

Alcon - Protocol C-02-42 (2003)
A Phase II, Dose-Ranging Study to Evaluate Rimexolone 0.005%, 0.05% and 01% Ophthalmic
Suspensions Versus Rimexolone Vehicle in Relieving the Ocular Signs and Symptoms of Dry Eye in
Patients with Autoimmune Connective Tissue Disease.
Alcon - Protocol C-02-52 (2003)
A Comparison of CIPRODEX (Ciprofloxacin 0.3%, Dexamethasone 0.1%) Ophthalmic Suspension, versus
CILOXAN (Ciprofloxacin 0.3%) Ophthalmic Solution, MAXIDEX (Dexamethasone 0.1% ) Ophthalmic
Suspension and CIPRODEX Vehicle for Treatment of Bacterial Blepharitis
Allergan – Protocol AG9524-001-00
A Multi-Center, Investigator-Masked, Randomized, Parallel-Group Study to Compare the Efficacy and
Safety of an Investigational Multi-Dose Emulsion eye Drop vs. Refresh Endura eye Drops for one Month
(with a Two –Month Masked Extension) in Subjects with Dry Eye
Alcon – Protocol C-04-35 (2004)
A Multi-Site, Open-Label Study of Patient Perception and Quality of Life Associated
With the Use of Olopatadine 0.2% in Patients with Allergic Conjunctivitis Who Were
Previously Treated with Olopatadine 0.1%
AstraZeneca – Protocol 5077IL/0089 (2003 – 2007)
A multicenter, open-label, flexible-dose, parallel-group evaluation of the cataractogenic
Potential of quetiapine fumarate (SEROQUEL) and risperidone (RISPERDAL) in the
Long-term treatment of patients with schizophrenia or schizoaffective disorder
Sucampo – Protocol SPI/506OK-0221; Phase II (2004)
A Prospective, Randomized, Phase II, Dose-Ranging, Double-Masked, Placebo-Controlled, Parallel-Dose,
Multicenter Trial to Evaluate the Efficacy and Safety of FK506 Eye Drops in Subjects with
Keratoconjunctivitis Sicca (Dry Eye)
Inspire – Protocol 03-109 (2004)
A Multi-Center, Parallel Group, Double-Masked, Randomized, Placebo-Controlled
Study of Multiple Ocular Instillations of diquafosol tetrasodium ophthalmic solution, 2% in Subjects with
Dry Eye Disease
Insite Vision – Protocol C01-401-004 (2004-2005)
A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0% Azasite Compared to 0.3%
Tobramycin Ophthalmic Solution in the Treatment of Bacterial Conjunctivitis
Otsuka Maryland Research Institute – Protocol 37E-03-201 (2004 –2006)
Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter,
Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group,
26-Week Study

Inspire – Protocol 031-402 (2005)
A Multi-Center, Double-Masked, Randomized Study Evaluating Measures of Patient
Preference of epinastine HCI ophthalmic solution, 0.05% (Elestat) versus olopatadine
Hydrochloride ophthalmic solution, 0.1% (Patanol) in Subjects with Symptomatic
Seasonal Allergic Conjunctivitis
Lantibio, Inc. – Moli 1901 DE – 002 (2005 – 2006)
A Phase 2 Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Dose Ranging
Study of Moli1901 Ophthalmic Solution in Subjects with Moderate to Severe Dry Eye Syndrome
Pfizer – Protocol A6641044 (2006)
A 12-Week, Randomized, Double-Masked, Parallel Group Comparison of Xalacom Given in the Evening,
Xalatan Given in the Evening, and Timolol Given in the Morning in Subjects With Open Angle Glaucoma
or Ocular Hypertension in the United States
Alcon – Protocol C-05-23 (2006)
A Double-Masked, Parallel Group, Randomized, Single-Dose Bioequivalent Study of Tobradex AF
Suspension and TOBRADEX Ophthalmic Suspension

Alcon – Protocol C-04-60 (2006)
A Comparative Study of Olopatadine 0.2% Versus Vehicle in Patients with Seasonal Allergic
Conjunctivitis or Rhinoconjunctivitis
Bausch & Lomb – Protocol 434 (2006 - 2007)
A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vigamox in the
Treatment of Bacterial Conjunctivitis

Alcon – Protocol C-05-31 (2006 – 2007)
A Randomized, Double-Masked Safety and Efficacy Study of FID # 109980 Compared to FID # 110656 in
the Treatment of Dry Eye
Vistakon – Protocol 06-003-09 (2006)
A Multi-Center, Randomized, Double-Masked Parallel Group Study Evaluating the Efficacy , Safety, and
Impact on Quality of Life of R89674 0.25% Ophthalmic Solution Compared to Vehicle or Olopatadine HCl
0.1% Ophthalmic Solution for 6 weeks in a Modified Environmental Mode in Adult and Pediatric Subjects
with Seasonal Allergic Conjunctivitis
Alcon – Protocol C-06-37 (2006 – 2007)
A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF
Suspension and TOBRADEX Ophthalmic Suspension
Novo Nordisk – Protocol NN1998-1683 (Secondary Site) (2007)
Inhaled Mealtime Insulin with the AERx iDMS plus Pioglitazone versus Pioglitazone alone in Type 2
Diabetes: A 26-Week, Open-Label, Multicentre, Randomised, Parallel Trial to Investigate Efficacy and
Safety
Novo Nordisk – Protocol NN1998-1540 (Secondary Site) (2007)
Inhaled Mealtime Insulin with the AERx iDMS plus Metformin &Glimepiride versus Rosiglitazone Plus
Metformin &Glimepiride in Type 2 Diabetes: A 26-Week, Open-Label, Multicentre, Randomized, Parallel
Trial to Investigate Efficacy and Safety
Alcon – Protocol SMA-06-24 (2007)
Examining the Efficacy, Safety and Improved Tolerability of Travoporost BAK Free Ophthalmic Solution
(Travatan-Z) Compared to prior Prostaglandin Therapy

Lux Biosciences – Protocol LX201-01 (2007)
A Multi-center, Placebo-Controlled, Randomized, Parallel-Group Dose-Ranging Study to Assess the
Efficacy and Safety of LX201 For Prevention of Corneal Allograft Rejection Episodes and Graft Failure
following Penetrating Keratoplasty with LX201 Implantation in Subjects Who Are At Increased
Imminological Risk
LuxBiosciences – Protocol LX201-02 (2007)
A Multi-center, Placebo-Controlled, Randomized, Parallel-Group, Dose-Ranging Study to Assess the
Efficacy and Safety of LX201 Implantation for the Prevention of Corneal Allograft Rejection Episodes or
Graft Failure in Subjects Who Have Experienced One or More Rejection Episodes following Penetrating
Keratoplasty

Aqumen Biopharmaceuticals – Protocol AQNA-DY001 (2007)
A Double-Masked, Randomized Study of the Safety and Effectiveness of DYME as an Agent for Selective
Staining of the Anterior Capsule during Cataract Surgery
Allergan – Protocol 198782-004-00 (2007)
A 6 Day, Phase 3, Multicenter, Randomized, Double-Masked, Parallel Study to Compare the Safety and
Efficacy of Gatifloxacin 0.5% Ophthalmic Solution BID with that of Vehicle in the Treatment of Acute
Bacterial Conjunctivitis

Sirion Therapeutics – Protocol ST-603-007 (2007)
A Multicenter, Randomized, Double-Masked Trial Evaluating the Efficacy and Safety of Cyclosporine A
Ophthalmic Solution, 0.1% (ST-603) Compared to Vehicle in the Treatment of Moderate to Severe Dry
Eye Syndrome
Allergan – Protocol 191578-005-00 (2007)
A Multi Center, Double-Masked, Randomized, Parallel-Group Study Evaluating the Safety and Efficacy of
a New Formulation of Ketorolac Tromethamine 0.45% Ophthalmic Solution Compared with Vehicle
Administered Preoperatively and Twice-Daily Postoperatively for Two Weeks for the Treatment of
Anterior Segment Inflammation, Pain, and Inhibition of Surgically Induced Miosis Following Cataract
Extraction with Posterior Chamber Intraocular Lens (IOL) Implantation
Aqumen – Protocol AQNA-DY002 (2008)
A Double-Masked, Randomized Study of the Safety and Effectiveness of DYME as an Agent for Selective
Staining of the Anterior Capsule during Cataract Surgery

Alcon – Protocol C-05-04 (2008)
An Evaluation of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates

ISTA – Protocol CL-S&E-1107071-P (2008)
A Multi-Center, Double-Blind, Vehicle-Controlled, Randomized Study of Ecabet Opthalmic Solution in
Patients with Dry Eye Disease

Inspire – Protocol 041-103 (2008)
A Multi-Center, Open-Label Randomized Study of the Pharmacokinetics of Azithromycin versus
Moxifloxacin in Conjunctiva and Aqueous Humor Following Single or Multiple Ocular Administration of
AzaSite Opthalmic Solution, 1% or Vigamox in Subjects Undergoing Routine Cataract Surgery

Aton Pharma – Protocol 07-004-12 (2008)
A Multi-Center Investigation of Patient Acceptability of LACRISERT

Allergan – Protocol 1920224-034 (2008)
An Eighteen Week, Multi-Center, Investigator-Masked, Randomized, Parallel-Group Study to Evaluate the
Safety and Efficacy of Bimatoprost 0.03% (Lumigan) Opthalmic Solution Once-Daily (QD) Compared
with Latanoprost 0.005% (Xalatan Opthalmic Solution QD Following Six Weeks of Treatment with
Xalatan QD in Subjects with Glaucoma or Ocular Hypertension

ISTA – CL-S&E-080207IP (2008)
Efficacy and Safety of Bromfenac Opthalmic Solution 0.18% QD vs. Xibrom (Bromfenac Opthalmic
Solution) 0.09% QD for Treatment of Ocular Inflammation, Pain, and Photophobia Associate with Cataract
Surgery

Alcon – Protocol SMA-07-15 (2008)
A Multi-Site, Randomized, Masked Study to Evaluate the Physical Effects of Systane versus Optive in
Subjects with Moderate to Severe Dry Eye
QLT Inc. – Protocol PPL GLAU 02 (2008)
A Phase II, Randomized, Masked, Parallel-Group Study of Safety and Preliminary Efficacy of the Punctum
Plug Delivery System in Subjects with Primary Open Angle Glaucoma or Ocular Hypertension

QLT Inc. – Protocol PPL GLAU 02 - extension (2008)
An Open-Label Extension Study to PPL GLAU 02 to Investigate the Long-Term Safety and Efficacy of the
Punctum Plug Delivery System for the Treatment of Primary Open-Angle Glaucoma or Ocular
Hypertension

QLT Inc.– Protocol PPDEV01 (2008)
A Device Evaluation Study to Assess the Physical and Clinical Performance of Prototype Punctal Plug
Design Iterations

Alcon – Protocol C-08-03 (2008)
An Evaluation of the Ocular Surface Health in Subjects Using TRAVATAN Z Opthalmic Solution Versus
Xalatan Opthalmic Solution
Alcon -- Protocol C-07-43 (2009)
A Clinical Safety and Efficacy Comparison of NEVANAC® 0.1% to Vehicle Following Cataract
Surgery in Diabetic Retinopathy Patients
INSPIRE -- Protocol number: 03-113 (2009)
A Multi-Center, Parallel-Group, Double-Masked, Randomized, Placebo-Controlled Study of the Effects if
diquafosol tetrasodium Ophthalmic Solution, 2% in Subjects with Dry Eye Disease and a Central Corneal
Staining Score of 3 (NEI Scale)
Alcon – Protocol C-07-40 (2009)
An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment
of Bacterial Conjunctivitis in the USA.
ISTA Pharmaceuticals – Protocol CL-PKT-0415083-P (2009)
A Multi-Center, Randomized, Double-Masked, Bioequivalence Study of T-PREDTM (prednisolone acetate
1% and tobramycin 0.3% ophthalmic suspension) Compared to Pred Forte® (prednisolone acetate) 1%
sterile ophthalmic suspension

QLT – Protocol PPL GLAU 03 (2009)
An Open-Label Phase 2 Study of the Latanoprost Punctal Plug Delivery System
(L-PPDS) in Subjects with Ocular Hypertension or Open-Angle Glaucoma.

QLT – Protocol PPL GLAU 04 (2009)
An Open-Label, Randomized, Phase 2 Study of the Effects of Artificial Tears Preserved With
Benzalkonium Chloride (AT-BAK) on the Response to the Latanoprost Punctal Plug Delivery System
(L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Sirion -- Protocol ST-603-010
A Multicenter, Randomized, Double-Masked, Vehicle-Controlled Pilot Study of the Efficacy and Safety of
Cyclosporine A Ophthalmic Solution (ST-603), 0.1% and 0.2% Compared to Vehicle in Subjects With Dry
Eye Disease
Alcon – Protocol C-09-001 (2009)
An Evaluation of the Ocular Surface Health in Subjects Using Travoprost APS Eye
Drops Solution Versus XALATAN® Eye Drops Solution

Alcon -- Protocol C-07-53 (2009)
An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of
Adenoviral Conjunctivitis
Alcon – Protocol C-08-077 (2009)
A Randomized, Double-Masked Study of AL-38583 0.05% ophthalmic solution and AL-38583 0.10%
ophthalmic solution Versus AL-38583 vehicle in the Treatment of Dry Eye

Inspire -- Protocol 044-101 (2009)
A Randomized, Multi-Center, Double-Masked, Placebo-Controlled, Parallel Group Safety and Efficacy
Study of Azithromycin Ophthalmic Solution, 1% versus Placebo for Two Weeks in Subjects with
Blepharitis
Inspire -- Protocol 044-102 (2009)
A Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy
Study of Azithromycin Ophthalmic Solution, 1% versus Placebo for Four Weeks in Subjects with
Blepharitis
Fovea Pharmaceuticals Protocol # FOV1101/CLIN/201/P (2009)
ORA Protocol # 08-003-27
A Multi-Centetr, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of
FOV1101-00 (Cyclosporine 0/1% or 0.2%) and Prednisolone Acetate 0.12% (Pred Mild) Compared to
Prednisolone Acetate 1% Alone or Vehicle Alone in Patients wirth Mild Ongoing Ocular Allergic
Inflammation

QLT Inc.– Protocol PPDEV02 (2009 - 2010)
A Device Evaluation Study to Assess the Physical and Clinical Performance of Prototype Punctal Plug
Design Iterations
QLT Inc. – Protocol PPL GLAU 03 (2009)
An Open-Label, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects
with Ocular Hypertension (OH) or Open Angle Glaucoma (OAG)
QLT Inc. – Protocol PPL GLAU 04 ) (2009)
An Open-Label, Randomized, Phase 2 Study of the Effects of Artificial Tears Preserved with
Benzalkonium Chloride (AT-BAK) on the Response to the Lataoprost Punctal Plug Delivery System (L-
PPDS) in Subjects with Ocular Hypertension (OH) or Open Angle Glaucoma (OAG)
QLT Inc. – Protocol PPL GLAU 07) (2009 - 2010)
An Open-Label, Phase 2 Study of Different Formulations (E1 and E2) of the Latanoprost Punctal Plug
Delivery System (L-PPDS) in Subjects with Ocular Hypertension (OH) or Open Angle Glaucoma (OAG)
INSPIRE -- Protocol 041-116 (2009 - 2010)
A Multi-Center, Double-Masked, Placebo-Controlled, Parallel-Group Randomized Study of the Safety and
Efficacy Study of Azithromycin Ophthalmic Solution, 1% versus Placebo for Four Weeks in Subjects with
Dry Eye Disease
Allergan – Protocol AG9965-002 (2009 – 2010)
A Multi-Center, Double-Masked, Randomized Study to Compare the Safety, Efficacy and Acceptability of
Two Next Generation Emulsion Eye Drop Formulations with Refresh Dry Eye Therapy® for Three Months
in Subjects with Dry Eye Disease
Bausch and Lomb – Protocol 576 (2009 – 2010)
A Randomized, Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of
Loteprednol Etabonate Gel, 0.5% versus Vehicle for the Treatment of Inflammation and Pain Following
Cataract Surgery
Eli Lilly – Protocol H8C-MC-LQBF (secondary site) (2009 -2010)
A Phase 2 Study of the Effects of LY545694, an iGluR5 Antagonist, in the Treatment of Subjects with
Painful Diabetic Neuropathy
Eli Lilly – Protocol H8C-MC-LQBG (secondary site) (2009 -2010)
A Phase 2 Study of the Effects of LY545694, an iGluR5 Antagonist, in the Treatment of Subjects with
Osteoarthritis Knee Pain
Sun Pharma - Protocol CLR 09 12 –(2010)
Latanoprost 0.005% Ophthalmic Solution (Test) and Xalatan® (Latanoprost0.005% Ophthalmic Solution -
Reference) When Administered Once Daily in Subjects With Open Angle Glaucoma or Ocular
Hypertension: A Clinical Non-Inferiority Study

Sun Pharma - Protocol CLR 09 13 – (2010)
A Clinical Evaluation of Safety of SPARC’s Latanoprost 0.005% Ophthalmic Solution When Administered
Once Daily in Subjects With Open Angle Glaucoma or Ocular Hypertetnsion: An Open Label Study
Ista Pharmaceuticals - Protocol S00007 (2010)
A dose-ranging study to evaluate the safety and efficacy of bromfenac
ophthalmic solution versus placebo in alleviating the signs and
symptoms of dry eye disease
Alcon - Protocol C-09-034 (2010)
A Multi-Center, Randomized, Double-Masked, Evaluation of the Safety and Efficacy of AL-38583
Ophthalmic Solution in Subjects with
Allergic Conjunctivitis Associated Inflammation (POC)
Fovea Pharmaceuticals – Protocol FOV1101/CLIN/202/P (Ora 10-003-03) (2010)
A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of
FOV1101-00 (Cyclosporine 0.01% or 0.02%) and Prednisolone Acetate 0.12% (Pred Mild(R)) Compared
to its Components and Vehicle in Patients with Mild Ongoing Ocular Allergic Inflammation
Acuela Inc.– Protocol ACU-RED 204 (2010)
A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the
Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo in Clearing of Fluorescein
Staining of the Central Cornea in Subjects with Keratoconjunctivitis Sicca (Dry Eye)
Bausch & Lomb – Protocol 631 (2010)
A Study to Evaluate the Safety of Besivance™
(besifloxacin ophthalmic suspension) 0.6% Compared to Vehicle Following
TID Dosing for 7 Days
Omeros - Protocol OMS302 C09-001 (2010)
A Study of Phenylephrine HCl's and Ketorolac Tromethamine’s Ability, Alone and in Combination, to
Maintain Mydriasis and Relieve Pain and Inflammation in Subjects Undergoing Unilateral Cataract
Extraction with Lens Replacement (CELR)
QLT, Inc. – Protocol PPL GLAU 11 (2010)
A Randomized, Masked, Phase 2 Study Evaluating Safety and Efficacy of the Latanoprost Punctal Plug
Delivery System (L-PPDS) and Comparing with that of Prostaglandin Eye Drops in Subjects With Ocular
Hypertension (OH) or Open-Angle Glaucoma (OAG)
Investigator Initiated Trial (Ranjan Malhotra, MD) – Protocol STB-01 (2010)
A Prospective Two-Site Study to Evaluate the Safety and Tolerance of Besivance versus Vigamox
Prophylactically Pre- and Post-Operatively in Subjects Undergoing Routine Cataract Surgery
Bausch & Lomb – Protocol 663 (2010 – 2011)
A Phase 3, Multicenter, Double-Masked, Vehicle-Controlled, Randomized, Parallel
Study to Assess the Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3%
in Subjects for the Treatment of Ocular Inflammation Following Uncomplicated
Cataract Surgery

Alcon – Protocol C-09-005 (2011)
Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular
Inflammation and Pain after Cataract Surgery

Alcon – Protocol C-10-090 (2011)
Aqueous Humor Concentration of Serum Amyloid A (SAA) in Patients Undergoing
Cataract Surgery

Alcon – Protocol C-10-039 (2011)
A Three-Month, Randomized, Double-Masked, Parallel-Group Study with a Planned
Three-Month Safety Extension of the Efficacy and Safety of a Fixed Combination of
Brinzolamide 1%/Brimonidine 0.2% compared to Brinzolamide 1% and Brimonidine
0.2% All Dosed Three Times Daily in Patients with Open-Angle Glaucoma and/or
Ocular Hypertension

Alcon – Protocol C-11-003 (2011)
Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3%
Compared to Nepafenac Ophthalmic Suspension 0.1% and
Vehicle for Prevention and Treatment of Ocular Inflammation
and Pain Associated with Cataract Surgery
Alcon – Protocol C-10-079 (2011)
Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort
in Patients with Severe Dry Eye
CXLUSA -- Protocol CXL-1 (2011)
Collagen Crosslinking with Ultraviolet-A in Asymmetric Corneas

TRANSCEND MEDICAL – Protocol TMI-09-01 (2011)
A Prospective, Randomized, Comparative, Multicenter Clinical Study to Assess the Safety and
Effectiveness of the Transcend CyPass Glaucoma Implant in Patients with Open Angle Glaucoma
undergoing Cataract Surgery
UNITED BIOSOURCE CORPORATION (2011)
Concept Elicitation and Cognitive Debriefing Interviews to Inform the Development of a Vision Symptom
Questionnaire for Patients Undergoing Photorefractive Keratectomy (PRK) or LASIK Surgeries
ALLERGAN – Protocol 10146X-001 (2011)
A Multi-Center, Investigator-Masked, Randomized, 4-Arm Parallel Group Study to Evaluate the Safety,
Efficacy and Acceptability of an Investigation Unit-Dose Eye Drop Formulation in Subjects with Dry Eye
Disease
ALCON Protocol C-09-076 (2011)
Clinical Investigation of AcrySof IQ Monofocal Toric Intraocular Lens Model
INSITE VISION INC – Protocol C-10-502-004 (2011)
A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and
Safety of ISV-502 (1.0% azithromycin and 0.1% dexamethasone) Compared to AzaSite Alone,
Dexamethasone 0.1% Alone, and Vehicle in the Treatment of Subjects with Non-Bacterial Blepharitis
QLT INC. – Protocol PPL Glau 13 (2011)
A Randomized Phase 2 Study of the Effect of Plug Placement on the Efficacy and Safety of the
Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects with Ocular Hypertension (OH) or Open-
Angle Glaucoma (OAG)
VIRACOR-IBT LABORATORIES – Protocol CL1104 (2011)
A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the
Treatment of Adenoviral Conjunctivitis
ACUCELA INC – Protocol ACU_RED-301 (2011)
A Phase 3 Study to Determine the Efficacy and Safety of Rebamipide in Subjects with Dry Eye Syndrome
SANTEN – Protocol 26-005 (2011)
A phase II, Prospective, Randomized, Double-Masked, Parallel-Group, Multi-Centered Study assessing the
Safety and efficacy of two Concentration of DE-101 (0.02% and 0.05% Rivoglitazone HCI) compared to
Placebo for the Treatment of Dry Eye Disease

OMEROS CORPORATION – Protocol OMS302-ILR-004 (2012)
A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Pharmacokinetics of OMS302
and the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects
Undergoing Intraocular Lens Replacement with Phacoemulsification
InSite – Protocol C-11-303-003 (2012)
A Phase 3, Multicenter, Randomized Double-Masked Study to Compare the Ocular Safety, Tolerability,
and Efficacy of ISV-303 (0.75% Bromfenac in Durasite) to Durasite Vehicle in Cataract Surgery Subjects
BAUSCH & LOMB –Protocol 790 (2012)
A Phase 3, Multicenter, Double-Masked, Vehicle-Controlled, Randomized, Parallel-Group Study to Assess
the Efficacy and Safety of Mapracorat Ophthalmic Suspension 3% in Subjects for the Treatment of Ocular
Inflammation Following Cataract Surgery
ALCON Protocol – C-11-20 (2012)
Post Approval Study of the AcrySof IQ Toric High Cylinder Power IOL Models SN6AT6-SN6AT9
ALLERAN – Protocol 195263-006 (2012)
Ophthalmic AGN-195263 for the Treatment of Meibomian Gland Dysfunction
UNITED BIOSOURCE CORPORATION – Protocol A-12063 (2012)
Focus Group Protocol to Gather Patient’s Perspectives about their Experiences with Ocular Allergy
Symptoms

Source: http://stlouisphysicianalliance.com/sites/default/files/malhotra%20cv.pdf