Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Experienced soft contact lens wearing subjects will be enrolled in this 1-week, post-market, bilateral, repeated measures, dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses. If unsuccessful in the dispensed lenses, additional lenses may be trialed. Once vision and lens fit are determined to be acceptable, eligible subjects will wear study lenses in both eyes for at least 8 hours per day (with the exception of the follow-up visits where the lenses should be worn for a minimum of 2 hours), for approximately 1 week (7 days +/-3 days). Measurements will be taken at the insertion visit and at the 7-day follow-up visit.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REVIVEâ„¢ Toric Soft Contact Lenses | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REVIVE Contact Lens | Device | REVIVE Contact Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean logMAR Visual Acuity at 6m | Mean logMAR Visual Acuity at 6m | At one week follow up |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb, Incorporated | Rochester | New York | 14609 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 31, 2025 | Feb 21, 2025 | 3 | ||
| Jun 11, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Jun 26, 2025 |
| 4 |