Research
Clinical Research Experiences
Alcon ILQ137-C002: Principal Investigator
Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix
THÉA LT4090-201: Principal Investigator
Efficacy and safety assessment of T4090 ophthalmic solution (preservative-free Kinezodianone R HCl 0.2% or 0.3%) versus Rhopressa® ophthalmic solution (preserved netarsudil 0.02%) in patients with open-angle glaucoma or ocular hypertension
Amneal MW230021: Principal Investigator
A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, bioequivalence study with clinical endpoint comparing generic bimatoprost ophthalmic solution 0.01% and LUMIGAN® (bimatoprost ophthalmic solution) 0.01% in the treatment of subjects with chronic open-angle glaucoma or ocular hypertension in both eyes
Oculis DX221: Principal Investigator
A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects with Diabetic Macular Edema
Bausch & Lomb #BL-SU01-ASRWE-4401: Principal Investigator
A Prospective, Multicenter, Open Label, Single Arm, Post-Marketing Clinical Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects Undergoing Cataract Extraction
VivaVision VVN461-CS-201: Principal Investigator
A phase 2, double-masked, randomized, vehicle-controlled study of VVN461 Ophthalmic Solution in treating post-operative ocular inflammation in subjects undergoing routine unilateral cataract surgery
Oculis DX220: Principal Investigator
A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of OCS-01 ophthalmic suspension in the Treatment of Inflammation and Pain Following Cataract Surgery
THÉA LT4032-302: Principal Investigator
Efficacy and safety assessment of T4032 (unpreserved bimatoprost 0.01%) versus Lumigan® 0.01% in ocular hypertensive or glaucomatous patients
Alcon ILS241-P002: Principal Investigator
Clareon Toric vs Eyhance Toric
KOWA K-321-302: Principal Investigator
A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week treatment and 14-week extension, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery
Oculis DX218: Principal Investigator
A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of OCS-01 eyedrops compared to Vehicle in the Treatment of Inflammation and Pain Following Cataract Surgery
CBCC/2021/025: Principal Investigator
A randomized, double-blind, multiple dose, parallel-group, two-arm, multicenter, bioequivalence study with clinical endpoint comparing bimatoprost ophthalmic solution 0.01% and LUMIGAN® (bimatoprost ophthalmic solution) 0.01% in the treatment of subjects with chronic open-angle glaucoma or ocular hypertension in both eyes
CBCC/2021/004: Principal Investigator
A randomized (1:1), double-masked, multi-center, two-treatment, parallel design, multiple dose bioequivalence study with clinical endpoint comparing Bimatoprost ophthalmic solution 0.01% of Mankind Pharma Limited, India with LUMIGAN® (Bimatoprost ophthalmic solution) 0.01% of Allergan, Inc., Irvine, CA 92612, U.S.A in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes
TearClear TC-002-301: Principal Investigator
A Prospective, Double-Masked, Randomized, Multi-center, Active-controlled, Parallel-group, 3-month Study Assessing the Safety and Ocular Hypotensive Efficacy of TC-002 Ophthalmic Solution (TearClear Latanoprost Ophthalmic Solution 0.005%) Compared to Latanoprost Ophthalmic Solution 0.005% in Subjects with Elevated Intraocular Pressure (CLEAR)
Formosa CPN-301: Principal Investigator
A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of APP13007 for the Treatment of Inflammation and Pain after Cataract Surgery
Centricity 13803: Sub-Investigator
A prospective randomized controlled masked study of endothelial cell condition after cataract surgery performed using manual capsulorhexis or the ZEPTO precision capsulotomy system
NCX-470-03: Principal Investigator
A Phase 3, Randomized, Multi-Regional, Double-Masked, Parallel-Group Trial Evaluating the Safety and Efficacy of NCX 470 0.1% vs. Latanoprost 0.005% in Subjects with Open-Angle Glaucoma or Ocular Hypertension (Denali)
NCX-470-02: Principal Investigator
A Phase 3, Randomized, Adaptive Dose-Selection, Multi-Regional, Double-Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost in Subjects with Open-Angle Glaucoma or Ocular Hypertension
Salvat CLOSE-2/ CLOBOF3-16IA02: Principal Investigator
A phase 3, multicenter, randomized, double-masked clinical trial to assess the efficacy and safety of clobetasol propionate ophthalmic nanoemulsion 0.05% compared to placebo in the treatment of inflammation and pain associated with cataract surgery
Bausch & Lomb #878 (CVisc50): Principal Investigator
A Multicenter, Controlled, Randomized, Monocular Safety and Effectiveness Study to Document the Safety and Effectiveness of a New Ophthalmic Viscosurgical Device (OVD) When Compared to a Control OVD
Bausch & Lomb #945: Principal Investigator
A Prospective, Multicenter, Randomized, Active-Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
Sun Pharma CLR_16_33: Principal Investigator
A Randomized, Multi-Center, Investigator-Masked, Parallel Group, Equivalence Study of Once Daily Brimonidine Tartrate Ophthalmic Suspension Compared with Three Times Daily Alphagan® P in Subjects with Open Angle Glaucoma or Ocular Hypertension
Alcon ILR431b-P001
Post Approval Study of the AcrySof® IQ ReSTOR Toric IOLs.
Oculis DX216: Principal Investigator
A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of Two Doses of OCS-01 compared to Vehicle in the Treatment of Inflammation and Pain Following Cataract Surgery
NCX-470-17001: Principal Investigator
A Phase 2, Randomized, Multicenter, Masked, Parallel-Group, Dose Response Study Evaluating the Safety and Efficacy of NCX 470 (3 doses: 0.021%, 0.042%, and 0.065%) vs. Latanoprost 0.005% in Subjects with Open-Angle Glaucoma or Ocular Hypertension
Bausch & Lomb #877 (DVisc 40): Principal Investigator
A multicenter, controlled, randomized, monocular trial evaluating the safety and effectiveness of the Bausch & Lomb DVisc40 dispersive OVD compared to the Alcon VISCOAT® dispersive OVD when used in cataract surgery
Senju SUN-131-03: Principal Investigator
A Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients with a Chalazion
Shire SHP640-303: Principal Investigator
A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis
Shire SHP640-301: Principal Investigator
A Phase 3, Multi-center, the Randomized, Double-Masked Study to Evaluate Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis
Aerie PG324-CS302: Principal Investigator
A prospective, double-masked, randomized, multi-center, active-controlled, parallel group, 3-month study assessing the safety and ocular hypotensive efficacy of PG324 Ophthalmic Solution compared to AR-13324 Ophthalmic Solution 0.02% and latanoprost ophthalmic solution 0.005% in subjects with elevated intraocular pressure
Aerie PG324-CS301: Principal Investigator
A prospective, double-mask randomized, multi-center, active-controlled, parallel-group 12-month study assessing the safety and ocular hypotensive efficacy of PG324 Ophthalmic Solution b compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in subjects with elevated intraocular pressure
Xigen SDD-1002-065: Principal Investigator
A Multicenter, Randomized, Double-Masked, Vehicle. Controlled, Parallel Group Controlled, Parallel Group Phase III Study of the Efficacy and Safety of a Single Sub-conjunctival Injection of XG-102 or the Reduction of Post-Cataract Surgery Intraocular Inflammation
Envisia ENV515-01: Sub-Investigator
A Multi-Center, Open-Label, Parallel-Arm, Randomized, Dose-Ranging Study of ENV515 (travoprost) Intracameral Implant in Subjects with Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma
Ocular Therapeutix OTX-14-003: Principal Investigator
A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain after Cataract Surgery
Ocular Therapeutix OTX-13-003: Principal Investigator
ReSure® Sealant Post-Approval Study: A Registry Evaluation of ReSure Sealant for Specified Adverse Ocular Events after Sealing Corneal Incisions in Patients Undergoing Clear Corneal Cataract Surgery
Alcon C-12-067: Principal Investigator
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation to Assess the Safety and Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery
Alcon C-11-020: Principal Investigator
The primary objective of this study is to demonstrate superiority of the AcrySof® IQ Toric High Cylinder Power study group (IOL Models SN6AT6-SN6AT9) to the AcrySof® IQAspheric NATURAL IOL Model SN60WF
Alcon C-11-003: Principal Investigator
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 C-09-055: Principal Investigator
Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain after Cataract Surgery
Bausch and Lomb #842: Principal Investigator
A Phase 3, Multi-Center, Double-Masked, Vehicle-Controlled, Randomized, Parallel-Group Study to Assess Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Bausch & Lomb #770: Principal Investigator
Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution with Timolol Maleate Ophthalmic Solution in Subjects with Open-Angle Glaucoma or Ocular Hypertension
Bausch & Lomb #577: Principal Investigator
A Randomized, Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Gel, 0.5% versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Alcon C-07-43: Sub-Investigator
A Clinical Safety and Efficacy Comparison of NEVANAC® 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients
ISTA Protocol CL-PKT-0415083-P: Sub-Investigator
A multi-center, randomized, Double-Masked, bioequivalence study of T-Pred (Prednisolone Acetate 1% and Tobramycin 0.3% ophthalmic suspension) compared to Pred-Forte® (Prednisolone Acetate) 1% sterile ophthalmic suspension
Bausch & Lomb #526: Sub-Investigator
Bausch & Lomb: BLP 358-006 A randomized, double-masked, multicenter comparison of the aqueous humor concentration of Loteprednol Etabonate following administration of Bausch & Lomb Loteprednol Etabonate and Tobramycin ophthalmic suspension 0.5%/0.3% or Lotemax (Loteprednol Etabonate and Tobramycin ophthalmic suspension 0.5%) during routine cataract surgery
Publications
Singh, R. P., Lehmann, R., Martel, J., Jong, K., Pollack, A., Tsorbatzoglou, A., Staurenghi, G., Cervantes-Coste Cervantes, G., Alpern, L., Modi, S., Svoboda, L., Adewale, A., & Jaffe, G. J. (2017). Nepafenac 0.3% after Cataract Surgery in Patients with Diabetic Retinopathy: Results of 2 Randomized Phase 3 Studies. Ophthalmology, 124(6), 776–785. https://doi.org/10.1016/j.ophtha.2017.01.036
Asrani, S., Robin, A. L., Serle, J. B., Lewis, R. A., Usner, D. W., Kopczynski, C. C., Heah, T., & MERCURY-1 Study Group (2019). Netarsudil/Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: Three-Month Data from a Randomized Phase 3 Trial. American journal of ophthalmology, 207, 248–257. https://doi.org/10.1016/j.ajo.2019.06.016
Korenfeld, M., Gira, J., Jong, K., Martel, J., Vold, S., Walters, T., Usner, D., & Donnenfeld, E. (2022). OCS-01 (Novel Topical Dexamethasone Formulation) in Inflammation and Pain Post Cataract Surgery: A Randomized, Double-Masked, Vehicle-Controlled Study. Clinical therapeutics, 44(12), 1577–1587. https://doi.org/10.1016/j.clinthera.2022.11.003
Vital M.C., Jong K.Y., Trinh C.E., Starck T., Sretavan D. (2023). Endothelial Cell Loss Following Cataract Surgery Using Continuous Curvilinear Capsulorhexis or Precision Pulse Capsulotomy. Clin Ophthalmol. 2023;17:1701-1708. https://doi.org/10.2147/OPTH.S411454
Under Review: “Efficacy and safety of clobetasol propionate ophthalmic nanoemulsion for treating intraocular inflammation and pain associated with cataract surgery: two phase 3 multicenter, randomized, placebo-controlled, double-blind clinical studies.”
