The 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-22 which is valid for 5 years (Till 27-Feb-2027 ) . The Institutional Ethics Committee of PBMA’s H. V. Desai Eye Hospital received NABH accreditation in September 2018.
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.
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.
Protocol No:CLR_10_31Protocol Title: Study to evaluate Safety of Benzalkonium Chloride Free Latanoprost Ophthalmic Solution 0.005% in Subjects with Glaucoma.
Protocol No:192024-049Protocol 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.
Protocol No:FST100-AVC-004Protocol 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.
Protocol No:IBPL_RN_01Protocol 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).
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”.
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.”
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.
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”.
Protocol No: EXJ821-P001 (C-13-039)
Protocol Title: Clinical Evaluation of Systane® Balance on Corneal Staining in Indian Subjects with Dry Eye.
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.
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
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).
Protocol No: CLS1003-302.
Protocol Title: Topaz A randomized, masked controlled trial to study the safety and efficacy of superchoroidal CLS-TA in combination with intravitreal anti-VEGF agent in subjects with retinal vein occlusion.
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.
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).
Protocol Title: A Double-Masked, Placebo-Controlled, Randomized, Phase II Clinical Trial To Assess The Efficacy Of IVIEW-1201 In The Treatment Of Acute Adenoviral Conjunctivitis.
Protocol No: 20-VIN-0084,
Protocol Title: A multicentre, randomized, assessor-blinded, active controlled, parallel group, two arm, bioequivalence study with clinical endpoint between Brinzolamide 10 mg/ml + Brimonidine tartrate 2 mg/ml eye drops suspension (Pharmathen S.A, Greece) and Simbrinza® (Brinzolamide 10 mg/ml + Brimonidine tartrate 2 mg/ml) eye drops suspension (Novartis Europharm Limited, Ireland) in the treatment of elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension.
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.
Protocol No: NEX-PED-005,
Protocol Title: A Phase 2, randomized, prospective, double-masked, vehicle-controlled study to assess the efficacy and safety of Nexagon® (NEXAGON) applied topically in subjects with corneal persistent epithelial defects (PED) resulting from severe ocular chemical and/or thermal injuries.
Protocol No.: ICR/19/016
Protocol Title: A randomized, multicenter, active controlled, parallel-group study to access efficacy and safety of fixed dose combination of Netarsudil and Latanoprost Ophthalmic solution (0.02% w/v) +(0.005% w/v) in comparison with Latanoprost eye drops (0.005% w/v) in patients with open angle glaucoma or ocular hypertension.
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.
Protocol No: 010906IN,
Protocol Title: LUMINA: A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 µg DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye.
Protocol No: LT4030-301,
Protocol Title:Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort ® UD in Ocular Hypertensive or Glaucomatous Patients.
Protocol No:CT-P42 3.1
Protocol Title:A Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in comparison with Eylea in Patients with Diabetic Macular Edema.
Protocol Title:A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Ranibizumab, Compared with Ranibizumab Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD).