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

Bausch & Lomb Incorporated32 enrolled

Overview

Experienced soft contact lens wearing subjects were enrolled in this 1-week, post-market, bilateral, repeated measures, dispensing study. All subjects were seen for a Screening/Dispensing Visit at which informed consent was obtained and eligibility was assessed. If subjects satisfied all eligibility criteria and none of the exclusion criteria, subjects were fit and dispensed study lenses. If unsuccessful in the dispensed lenses, additional lenses were trialed. Once vision and lens fit were determined to be acceptable, eligible subjects wore study lenses in both eyes for at least 8 hours per day (with the exception of the follow-up visits where the lenses were worn for a minimum of 2 hours), for approximately 1 week (7 days +/-3 days). Measurements were taken at the insertion visit and at the 7-day follow-up visit.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Refractive Ametropia Astigmatism

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Mean logMAR Visual Acuity at 6m

Mean binocular high-contrast, high-illumination (HCHI) logMAR visual acuity at 6 meters, measured with the REVIVE™ Toric study contact lenses in place at the 1-week follow-up visit. Acuity was recorded on a logMAR chart (each letter = 0.02 logMAR); lower/more-negative values indicate better visual acuity.

Time frame: 1-Week Follow-up Visit (approximately 7 ± 3 days after the dispensing visit)