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NCT04139798 · ClinicalTrials.gov registry record · Phase 3
Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
A Phase 3 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 599
- Enrollment target
NCT04139798: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.
NCT04139798 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 599 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04139798, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 599 participants
- Enrollment target
Study Summary
This trial will evaluate 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
Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 5 subregions ranging from 0-15.
Interventions
- DRUG Placebo
- DRUG NOV03
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 599 participants |
| Start Date | 2020-07-20 |
| Est. Completion | 2021-03-12 |
| Phase | Phase 3 |
What the finished NCT04139798 record still lists
NCT04139798 is an interventional study that assigns participants to a tested intervention. The registered 599 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 (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04139798 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04139798 about?
NCT04139798 is a clinical study titled "Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)". This trial will evaluate 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 NCT04139798?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 599 participants. The study started on 2020-07-20. Estimated completion is 2021-03-12.
What interventions are being tested in trial NCT04139798?
The interventions under investigation include: Placebo (DRUG), NOV03 (DRUG).
Who is sponsoring clinical trial NCT04139798?
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 NCT04139798's enrollment target sits among peer trials
599 638th of 2000 higher than 1,361 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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