ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

Phase 3 Completed 834 enrolled Novaliq GmbH

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).

Timeline

Start: 2020-12-05
Primary completion: 2021-09-03
Completion: 2021-10-08

Outcome

Mixed primary results

paper at day 29 (change [∆] = -0.4; 95% CI, -0.8 to 0; P = .03). PMID 37022717 ↗

paper -12.2 points for cyclosporine and -13.6 points for vehicle (∆ = 1.4; 95% CI, -1.8 to 4.6; P = .38). PMID 37022717 ↗

Publications

Akpek EK, Wirta DL, Downing JE, Tauber J, Sheppard JD, Ciolino JB, Meides AS, Krosser S. Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease: The ESSENCE-2 Randomized Clinical Trial. JAMA Ophthalmol. 2023 May 1;141(5):459-466. doi: 10.1001/jamaophthalmol.2023.0709.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclosporine	Peptide	0.1 %	Topical