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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03388138 | Clinical Evaluation of Etafilcon A With Ketotifen | PHASE2 | COMPLETED | 143 | — | — | Dec 6, 2017 | Feb 9, 2018 | Mar 17, 2022 | 6 | United States |
Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.
Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.
| Arm | Type | Description |
|---|---|---|
| K-Lens | ACTIVE_COMPARATOR | etafilcon A with ketotifen. Subjects between the ages of 18-40 will be randomized into the K-Lens arm and will be scheduled for a total of two study visits with approximately 6-9 days in between. |
| Placebo Contact Lens | PLACEBO_COMPARATOR | 1-Day Acuvue. Subjects between the ages of 18-40 will be randomized into the Placebo arm and will be scheduled for a total of two study visits with approximately 6-9 days in between. |
| Name | Type | Description |
|---|---|---|
| etafilcon A with ketotifen | COMBINATION_PRODUCT | Etafilcon A with ketotifen |
| 1-Day ACUVUE | DEVICE | 1-Day ACUVUE |
Inclusion Criteria: * Potential subjects must satisfy all of the following criteria to be enrolled in the study 1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Appear able and willing to adhere to the instructio...