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

NCT06053736 | Completed FDA Device

• 1 other identifier: ROC2-23-008
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean logMAR Visual Acuity at 6m

  Mean logMAR Visual Acuity at 6m

  At one week follow up

Study Arms (1)

REVIVE™ Toric Soft Contact Lenses

EXPERIMENTAL

Device: REVIVE Contact Lens

Interventions

REVIVE Contact Lens DEVICE

REVIVE Contact Lens

REVIVE™ Toric Soft Contact Lenses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
• Have no active ocular disease or allergic conjunctivitis.
• Not be using any topical ocular medications.
• Be willing and able to follow instructions.
• Have signed a statement of informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb, Incorporated

Rochester, New York, 14609, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: October 4, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)