Trials / Completed
CompletedNCT04567329
Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)
A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled Trial to Evaluate the Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 620 (actual)
- Sponsor
- Bausch & Lomb Incorporated · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of this trial are to assess the efficacy, safety, and tolerability of NOV03 ophthalmic solution in comparison to a saline control for the treatment of the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NOV03 | 100% perfluorohexyloctane |
| DRUG | Saline Solution | 0.6% sodium chloride solution |
Timeline
- Start date
- 2020-11-18
- Primary completion
- 2021-08-30
- Completion
- 2021-08-30
- First posted
- 2020-09-28
- Last updated
- 2024-08-19
- Results posted
- 2024-08-19
Locations
35 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04567329. Inclusion in this directory is not an endorsement.