CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 620 enrolled
Drug / intervention
NOV03 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04567329
NCT04567329Phase 3Completed
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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)

Bausch & Lomb Incorporated·interventional·Posted Sep 28, 2020·Updated Aug 19, 2024

In Brief

A Phase 3 clinical trial evaluating NOV03 and Saline Solution for Dry Eye Disease. Completed, enrolled 620 participants across 35 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedSep 28, 2020
Enrollment StartNov 18, 2020
Primary CompletionAug 30, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.8 years ago

Interventions

NOV03drug

100% perfluorohexyloctane

Saline Solutiondrug

0.6% sodium chloride solution