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NCT04567329 · ClinicalTrials.gov registry record · Phase 3
Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)
A Phase 3 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 620
- Enrollment target
NCT04567329: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.
NCT04567329 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 620 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04567329, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 620 participants
- Enrollment target
Study 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).
Primary Outcome
The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section).
Interventions
- DRUG Saline Solution
- DRUG NOV03
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 620 participants |
| Start Date | 2020-11-18 |
| Est. Completion | 2021-08-30 |
| Phase | Phase 3 |
What the finished NCT04567329 record still lists
NCT04567329 is an interventional study that assigns participants to a tested intervention. The registered 620 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline Solution is the first listed.
NCT04567329 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04567329 about?
NCT04567329 is a clinical study titled "Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)". 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).
What is the current status of trial NCT04567329?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 620 participants. The study started on 2020-11-18. Estimated completion is 2021-08-30.
What interventions are being tested in trial NCT04567329?
The interventions under investigation include: Saline Solution (DRUG), NOV03 (DRUG).
Who is sponsoring clinical trial NCT04567329?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04567329's enrollment target sits among peer trials
620 589th of 2000 higher than 1,410 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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