CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Summary
The objective of this study is to assess the efficacy, safety, and tolerability of CyclASol Ophthalmic Solution in comparison to vehicle for the treatment of the signs and symptoms of DED.
Timeline
- Start
- 2017-10-19
- Primary completion
- 2018-05-22
- Completion
- 2018-06-20
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
paper Treatment with CyclASol 0.1% was superior to vehicle in the primary endpoint: total corneal fluorescein staining at week 4 (Δ -0.8; 95% confidence interval, -1.3 to -0.4; P = 0.0002, analysis of covariance). reads as mixed primary results PMID 34481407 ↗
paper The study did not statistically meet its second hierarchically tested primary endpoint: Ocular Surface Disease Index score (P = 0.2634). reads as mixed primary results PMID 34481407 ↗
release “The ESSENCE trial met its primary endpoint at 4 weeks” reads as met primary endpoint novaliq.com ↗
Publications
- Results Sheppard JD, Wirta DL, McLaurin E, Boehmer BE, Ciolino JB, Meides AS, Schluter T, Ousler GW, Usner D, Krosser S. A Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease: Results of the Randomized Phase 2B/3 ESSENCE Study. Cornea. 2021 Oct 1;40(10):1290-1297. doi: 10.1097/ICO.0000000000002633.
- Akpek EK, Sheppard JD, Hamm A, Angstmann-Mehr S, Krosser S. Efficacy of a new water-free topical cyclosporine 0.1% solution for optimizing the ocular surface in patients with dry eye and cataract. J Cataract Refract Surg. 2024 Jun 1;50(6):644-650. doi: 10.1097/j.jcrs.0000000000001423.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporine | Peptide | 0.1 % | Topical |