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

NCT ID: NCT06053736

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-04
• Study Completion Date: 2023-12-15

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.

Conditions

Refractive Ametropia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

REVIVE™ Toric Soft Contact Lenses

Group Type: EXPERIMENTAL

REVIVE Contact Lens

Intervention Type: DEVICE

REVIVE Contact Lens

Interventions

REVIVE Contact Lens

REVIVE Contact Lens

Intervention Type: DEVICE

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bausch & Lomb, Incorporated

Rochester, New York, United States

Countries

United States

Other Identifiers

ROC2-23-008

Identifier Type: -

Identifier Source: org_study_id