CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 599 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/NCT04139798
NCT04139798Phase 3Completed
CompareCT.gov

A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled Trial to Evaluate the Effect of NOV03 (Perfluorohexyloctane) on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)

Bausch & Lomb Incorporated·interventional·Posted Oct 25, 2019·Updated Oct 23, 2024

In Brief

A Phase 3 clinical trial evaluating NOV03 and Placebo for Dry Eye Disease (DED). Completed, enrolled 599 participants across 29 sites.

Detailed 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).

Study Details

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

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 25, 2019
Enrollment StartJul 20, 2020
Primary CompletionMar 12, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 6.7 years ago

Interventions

NOV03drug

100% Perfluorohexyloctane

Placebodrug

Saline solution (0.6% sodium chloride solution)