NCT04139798

Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 599 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Dry Eye Disease (DED)

Interventions

Type	Name	Description
DRUG	NOV03	100% Perfluorohexyloctane
DRUG	Placebo	Saline solution (0.6% sodium chloride solution)

Timeline

• Start date: 2020-07-20
• Primary completion: 2021-03-12
• Completion: 2021-03-12
• First posted: 2019-10-25
• Last updated: 2024-10-23
• Results posted: 2024-10-23

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated drug study