Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04567329 | Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study) | PHASE3 | COMPLETED | 620 | — | — | Nov 18, 2020 | Aug 30, 2021 | Aug 19, 2024 | 35 | United States |
The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section).
Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness").
| Arm | Type | Description |
|---|---|---|
| NOV03 | EXPERIMENTAL | 100% perfluorohexyloctane 4 times daily (QID) |
| Saline solution | PLACEBO_COMPARATOR | 0.6% sodium chloride solution 4 times daily (QID) |
| Name | Type | Description |
|---|---|---|
| NOV03 | DRUG | 100% perfluorohexyloctane |
| Saline Solution | DRUG | 0.6% sodium chloride solution |
Inclusion Criteria: 1. Was at least 18 years of age at the time of consent. 2. Provided written informed consent. 3. Had a subject-reported history of DED in both eyes for at least 6 months prior to Visit 0. 4. Had a TFBUT ≤5 seconds at Visit 0 and Visit 1. 5. Had an OSDI score ≥25 at Visit 0 and V...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | ABBV-444, REFRESH OPTIVE UD, ABBV-319 |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE2 | GRF312 5% |
| Bausch + Lomb Corporation | BLCO | 1 | PHASE2 | Lifitegrast/Perfluorohexyloctane Fixed Dose Combination, Perfluorohexyloctane, Vehicle |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | VSJ-110 |
| Oculis Holding AG | OCS | 1 | PHASE2 | licaminlimab |
| Alcon AG | ALC | 2 | NA | Undisclosed |
| Harrow, Inc. | HROW | 1 | — | Undisclosed |