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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03198000 | A Study to Evaluate the Efficacy of Investigational OTC Eye Drops | PHASE3 | COMPLETED | 120 | — | — | Jun 28, 2017 | Jul 21, 2017 | May 24, 2023 | 1 | United States |
Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
| Arm | Type | Description |
|---|---|---|
| Formula # 13418-148 | EXPERIMENTAL | - |
| Formula # 13418-158 | EXPERIMENTAL | - |
| Control Formula # PF004390 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| F# 13418-148 Eye Drops | DRUG | ocular clear liquid. Tetrahydrozoline 0.05%; Glycerin 0.40% 1-2 drops will be instilled as instructed over one day |
| F#13418-158 Eye Drops | DRUG | ocular clear liquid Tetrahydrozoline 0.05%; Glycerin 0.20%, Hypromellose 0.2%, Polyethylene glycol 400 1.0% 1-2 drops will be instilled as instructed over one day |
| F# PF-004390 Eye Drops | DRUG | Ocular clear liquid Tetrahydrozoline 0.05%; 1-2 drops will be instilled as instructed over one day |
Inclusion Criteria: 1. Able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment; 2. Able and willing to provide a signed and dated Informed Consent document and Authorization for the Rel...