drugset / Trial / NCT04567329
Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2020-11-18
- Primary completion
- 2021-08-30
- Completion
- 2021-08-30
Outcome
Met primary endpoint
paper tCFS (-2.3 vs -1.1; LS mean treatment difference, -1.2 [95% confidence interval -1.7 to -0.8]; P < .001) PMID 36948372 ↗
paper visual analog scale dryness score (-29.4 vs -19.2; LS mean treatment difference, -10.2 [95% CI -14.4 to -6.1]; P < .001) PMID 36948372 ↗
release “In addition to meeting both primary sign and symptom efficacy endpoints, NOV03 was shown to be very well tolerated in the MOJAVE study.” 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.
- Sheppard JD, Kurata F, Epitropoulos AT, Krosser S, Vittitow JL; MOJAVE Study Group. NOV03 for Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction: The Randomized Phase 3 MOJAVE Study. Am J Ophthalmol. 2023 Aug;252:265-274. doi: 10.1016/j.ajo.2023.03.008. Epub 2023 Mar 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Perfluorohexyloctane | Unknown | 100 % | Other |