Trials / Completed
CompletedNCT04523129
ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
A Phase 3, Multi-center, Randomized, Double-masked, Vehicle-controlled Clinical Trial to Assess the Efficacy and Safety of Topical CyclASol® for the Treatment of Dry Eye Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 834 (actual)
- Sponsor
- Novaliq GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This Phase 3 study will assess the efficacy, safety and tolerability of CyclASol 0.1% Ophthalmic Solution administered bilaterally twice daily versus vehicle.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CyclASol topical ocular, eye drops | Cyclosporine A solution in vehicle |
| DRUG | Vehicle topical ocular, eye drops | Vehicle |
Timeline
- Start date
- 2020-12-05
- Primary completion
- 2021-09-03
- Completion
- 2021-10-08
- First posted
- 2020-08-21
- Last updated
- 2023-03-10
- Results posted
- 2023-03-10
Locations
27 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04523129. Inclusion in this directory is not an endorsement.