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

Not Applicable

Completed

• Conditions: Refractive Ametropia
• Interventions: Device: REVIVE Contact Lens

• Registration Number: NCT06053736
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-26
• Study Start: 2023-10-04
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent

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Exclusion Criteria

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
REVIVE™ Toric Soft Contact Lenses	REVIVE Contact Lens	-

Primary Outcome Measures

Name	Time	Method
Mean logMAR Visual Acuity at 6m	At one week follow up	Mean logMAR Visual Acuity at 6m

Trial Locations

Locations (1)

Bausch & Lomb, Incorporated; 🇺🇸 Rochester, New York, United States