NCT06053736

1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Refractive Ametropia

Interventions

Type	Name	Description
DEVICE	REVIVE Contact Lens	REVIVE Contact Lens

Timeline

• Start date: 2023-10-04
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2023-09-26
• Last updated: 2024-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study