Clinical Trials

Institutional Ethics Committee of PBMA’s H. V. Desai Eye Hospital has been registered with DCGI under rule 122DD of the Central Drug Standard Control Organization (CDSCO) Re-Registration Number– ECR/234/Inst/MH/2013/RR-19 which is valid for 3 years (Till 21 April 2022). Institutional Ethics Committee of PBMA’s H. V. Desai Eye hospital has received NABH accreditation in Sep. 2018.

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Completed Clinical Trial +

Sponsor: Lux bioscience

Protocol Title: 1. LX201-01.- A multi center, placebo –controlled, randomized, Parallel-group, Dose Ranging study to access the efficacy and safety of LX201 for prevention of corneal Allograft Rejection episodes and graft failure following penetrating ketatoplasty with LX 201 implantation in subjects who are at increased immunological Risk.

2. LX 201-02- A multi center, placebo– controlled, randomized, Parallel-group, Dose Ranging study to access the efficacy and safety of LX201 for the prevention of corneal allograft rejection episodes Or Graft failure in subjects who experienced one or more rejection episodes following penetrating keraoplasty.

Sponsor: Sun Pharma Advance Research Company

Protocol No:CLR_08_01
Protocol Title: Comparison of the efficacy and safety of Latanoprost 0.005% (Xalatan ® Reference) and Latanoprost 0.005% administered once daily in open angle glaucoma and ocular hypertension.

Sponsor: Sun Pharma Advance Research Company

Protocol No:CLR_10_31
Protocol Title: Study to evaluate Safety of Benzalkonium Chloride Free Latanoprost Ophthalmic Solution 0.005% in Subjects with Glaucoma.

Sponsor: Allergan Health Care India Pvt Ltd.

Protocol No:192024-049
Protocol Title: Efficacy and safety of fixed dose combination of latanoprost 0.005% and timolol 0.5% ophthalmic solution (sun pharma advanced research company Ltd.) in patients with open angle glaucoma or ocular hypertension: a randomized, evaluator masked, parallel Group, active controlled study.

Sponsor: Foresight Biotherapeutics, Inc. New York.

Protocol No:FST100-AVC-004
Protocol Title: A proof-of-concept, multi-center, randomized, double-masked study to evaluate the Clinical efficacy and safety of FST-100 (0.1% Dexamethasone and 0.6 % PVP-Iodine ) Ophthalmic suspension in the treatment of Acute Adenoviral conjunctivitis.

Sponsor: Intas Biopharmaceutical Ltd. Ahmedabad.

Protocol No:IBPL_RN_01
Protocol Title: A Prospective, Comparative, Assessor Blind, Randomized, Multicenteric Phase III study to compare the safety and efficacy of Ranibizumab of Intas Biopharmaceuticals Ltd. in comparison with Lucentis of Novartis in patients of wet AMD (Age related Macular Degeneration).

Sponsor: Sun Pharma Advance Research Company, Mumbai.

Protocol No:CLR_11_07
Protocol Title: “Aqueous Humor Bioequivalence Study of Loteprednol 0.5 %, Sun Pharmaceutical Industries Ltd. (SPIL) and Lotemax in Patients Undergoing Cataract Surgery: A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Cross over, Active Controlled Study”.

Sponsor: Sun Pharmaceutical Ltd.

Protocol No: SUB/SFCB/0110
Protocol Title: “Evaluation and efficacy and safety of two fixed dose combination of carbonic anhydrate inhibitor and beta blocker for the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma a randomized open label, comparative, multicentric study.”

Sponsor: Lotus Lab

Protocol No: WAT/BNZL/2014
Protocol Title: A multicentre, double blind, active controlled, parallel group, two arm, bioequivalence study with clinical endpoint comparing Brinzolamide 1% ophthalmic suspension (manufactured by Indoco Remedies Ltd., for Watson PharmaPvt Ltd.), to Brinzolamide (Azopt®) 1% ophthalmic suspension of Alcon Laboratories Inc., in the treatment of Chronic open angle glaucoma or Ocular hypertension in both eye.

Sponsor: Lotus Lab

Protocol No: WAT/LTPNL/2015
Protocol Title: An Open Label, Randomized, Multicentric, Two Treatment, Single Dose, Parallel Group Two Stage Adaptive Design Bioequivalence Study of Loteprednol Etabonate Ophthalmic Suspension, 0.5 % in Aqueous Humor of Patients Undergoing Indicated Cataract Surgery”.

Sponsor: Alcon Laboratories India Pvt., Ltd.

Protocol No: EXJ821-P001 (C-13-039)
Protocol Title: Clinical Evaluation of Systane® Balance on Corneal Staining in Indian Subjects with Dry Eye.

Sponsor: pSivida Corp., 400 Pleasant Street, Watertown, MA 02472 USA.

Protocol No: PSV-FAI-001
Protocol Title: A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects with Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye.

Sponsor: Clearside Biomedical Inc , USA

Protocol No: CLS1001-301
Protocol Title: (PEACHTREE) A Phase 3, Randomized, Masked, Controlled Clinical Trial to Study the Safety and Efficacy of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the Treatment of Subjects with Macular Edema associated with Non-Infectious UvEitis

Sponsor: Intas Pharmaceutical

Protocol No: 045-15
Protocol Title: A prospective, multicenter clinical study to assess safety immunogenicity and efficacy of Ranibizumab (Intas Pharmaceutical Limited) for the treatment of wet AMD (Age Related Macular Degeneration).

Sponsor:pSivida Corp, 400 Pleasant Street, Watertown, MA 02472 USA.

Protocol No: PSV-FAI-005
Protocol Title: A Multi-Center, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects with Chronic Non-Infectious Uveitis affecting the Posterior Segment of the Eye.

Sponsor: Quark pharmaceutical, USA

Protocol No: QRK207
Protocol Title: A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI- 1007 Delivered by Single or Multi-Dose Intravitreal Injection(s) to Subjects with Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION).

Ongoing Clinical Trial+

CRO: Syneos Health, United States

Protocol No: XBR1001
Protocol Title:Xplore: A Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of Xlucane versus Lucentis® in Patients with Neovascular Age-Related Macular Degeneration.

CRO: Syneos Health, United States

Protocol No: QL1205-002
Protocol Title: A Randomized, Phase 3, Double-masked, Parallel-group, Multicenter Study to Compare Efficacy and Safety of QL1205 Versus Lucentis® in Subjects With Neovascular Age-related Macular Degeneration.