Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi 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).
Timeline
- Start
- 2020-07-20
- Primary completion
- 2021-03-12
- Completion
- 2021-03-12
Outcome
Met primary endpoint
paper Reductions in tCFS and VAS eye dryness scores were greater for perfluorohexyloctane versus control. PMID 39564145 ↗
paper In the overall patient population, least-squares mean treatment difference was -1.1 (95% CI: -1.41 to -0.79; p<0.0001) for tCFS PMID 39564145 ↗
paper and -9.0 (95% CI: -11.90 to -6.00; p<0.0001) for VAS eye dryness. PMID 39564145 ↗
release “All Primary and Secondary Endpoints Were Achieved” novaliq.com ↗
release “These data show that the GOBI trial met both co-primary endpoints” novaliq.com ↗
Publications
- Fahmy AM, Harthan JS, Evans DG, Greiner JV, Tauber J, Sheppard JD, Krosser S, Vittitow JL. Perfluorohexyloctane ophthalmic solution for dry eye disease: pooled analysis of two phase 3 clinical trials. Front Ophthalmol (Lausanne). 2024 Nov 5;4:1452422. doi: 10.3389/fopht.2024.1452422. eCollection 2024.
- Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Perfluorohexyloctane | Unknown | 100 % | Other |