OCS-01 in Treating Inflammation and Pain in Post-cataract Patients
Summary
The DX-216 trial is a randomized, double-masked, placebo (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. The primary objective is to evaluate the efficacy and safety of OCS-01 compared to placebo and the secondary objective is to evaluate the optimal dosing frequency (once a day \[QD\] or twice a day \[BID\]).
Timeline
- Start
- 2019-09-27
- Primary completion
- 2020-01-31
- Completion
- 2020-01-31
Outcome
Mixed primary results
paper Primary end points were absence of anterior chamber cells (ACC; cells = 0) at Day 15 PMID 36503736 ↗
paper and absence of pain (score of "0") at postoperative Day 4. PMID 36503736 ↗
paper On Day 15, a greater reduction in the percentage of eyes with ACC grade 0 was observed in the OCS-01 once daily (51%) PMID 36503736 ↗
paper P = 0.0009 and P < 0.0001, respectively, using a Pearson χ2 test). PMID 36503736 ↗
paper statistical significance was reached for OCS-01 once daily (P = 0.005) and OCS-01 BID (P = 0.074) compared with vehicle. PMID 36503736 ↗
Publications
- Background Ohira A, Hara K, Johannesson G, Tanito M, Asgrimsdottir GM, Lund SH, Loftsson T, Stefansson E. Topical dexamethasone gamma-cyclodextrin nanoparticle eye drops increase visual acuity and decrease macular thickness in diabetic macular oedema. Acta Ophthalmol. 2015 Nov;93(7):610-5. doi: 10.1111/aos.12803. Epub 2015 Jul 23.
- Background Tanito M, Hara K, Takai Y, Matsuoka Y, Nishimura N, Jansook P, Loftsson T, Stefansson E, Ohira A. Topical dexamethasone-cyclodextrin microparticle eye drops for diabetic macular edema. Invest Ophthalmol Vis Sci. 2011 Oct 10;52(11):7944-8. doi: 10.1167/iovs.11-8178.
- Background Johannesson G, Moya-Ortega MD, Asgrimsdottir GM, Lund SH, Thorsteinsdottir M, Loftsson T, Stefansson E. Kinetics of gamma-cyclodextrin nanoparticle suspension eye drops in tear fluid. Acta Ophthalmol. 2014 Sep;92(6):550-6. doi: 10.1111/aos.12334. Epub 2013 Dec 24.
- Background Saari KM, Nelimarkka L, Ahola V, Loftsson T, Stefansson E. Comparison of topical 0.7% dexamethasone-cyclodextrin with 0.1% dexamethasone sodium phosphate for postcataract inflammation. Graefes Arch Clin Exp Ophthalmol. 2006 May;244(5):620-6. doi: 10.1007/s00417-005-0124-2. Epub 2005 Oct 11.
- Korenfeld M, Gira J, Jong K, Martel J, Vold S, Walters T, Usner D, Donnenfeld E. OCS-01 (Novel Topical Dexamethasone Formulation) in Inflammation and Pain Post Cataract Surgery: A Randomized, Double-Masked, Vehicle-Controlled Study. Clin Ther. 2022 Dec;44(12):1577-1587. doi: 10.1016/j.clinthera.2022.11.003. Epub 2022 Dec 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 1.5 % | Topical |