Trials / Completed
CompletedNCT03292809
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
A Phase 2b/3, Multicenter, Randomized, Double-masked, Vehicle-controlled Clinical Study to Assess the Efficacy and Safety of Topical CyclASol® for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) (ESSENCE Trial)
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 328 (actual)
- Sponsor
- Novaliq GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This Phase 2b/3 study will assess the efficacy, safety and and tolerability of CyclASol Ophthalmic Solution as one drop 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
- 2017-10-19
- Primary completion
- 2018-05-22
- Completion
- 2018-06-20
- First posted
- 2017-09-26
- Last updated
- 2022-12-22
- Results posted
- 2021-05-21
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03292809. Inclusion in this directory is not an endorsement.