A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: Marketed daily disposable contact lens
Device: Bausch & Lomb contact lens

Registration Number: NCT01130974

Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary: The objective of this study is to evaluate the safety and efficacy of the Bausch \& Lomb daily disposable tint contact lens (Test) compared to a currently marketed daily disposable cosmetic tint contact lens (Control).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

Inclusion Criteria

Subjects must have clear central corneas and be free of any anterior segment disorders.
Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
Subjects must be of Asian descent.
Subjects must require plano or myopic correction and must require contact lens correction from plano to -6.00 D in both eyes.

Exclusion Criteria

Subjects who have any systemic disease affecting ocular health.
Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
Subjects with an active ocular disease or are using any ocular medication.
Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
Subjects who currently wear monovision, multifocal, or toric contact lenses.
Subjects who are adapted wearers of 1-Day Acuvue Define daily disposable cosmetic tint contact lenses.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Marketed daily disposable contact lens	Marketed daily disposable contact lens	Marketed daily disposable cosmetic tint contact lens
Bausch & Lomb contact lens	Bausch & Lomb contact lens	Bausch \& Lomb daily disposable cosmetic tint contact lens

Primary Outcome Measures

Name	Time	Method
Slit Lamp Findings	Summarized over all follow-up visits through 1 month	Graded Slit lamp findings (epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates) \> grade 2 over all follow-up visits, summarizes the worst case over all follow-up visits. Graded 0-4 with 0=none and 4=severe
logMAR Visual Acuity (VA)	2 week and 1 month follow-up	Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit

Secondary Outcome Measures

Name	Time	Method
Lens Movement	Summarized over all follow-up visits through one month	Lens movement was assessed as adequate, excessive (\> 0.6 mm), insufficient (\< 0.2 mm), or adherence. Suboptimal lens movement was defined as a rating other than adequate.
Lens Wettability	Summarized over all follow-up visits through 1 month	Lens wettability was rated as Grade 4-0. Grade 4 = 100% of anterior surface wettable (optimal); Grade 3 = presence of small (\< 0.1 mm), individual, discrete non-wetting areas (slight); Grade 2 = presence of single area of non-wetting between 0.1 mm and 0.5 mm in size (mild); Grade 1 = presence of several areas on non-wetting, each between 0.1 mm and 0.5 mm in size (moderate); Grade 0 = presence of one or more non-wetting areas \> 0.5 mm in size (severe). Suboptimal lens wettability was defined as a rating other than Grade 4, ie slight, mild, moderate, or severe ratings. Over All Visits summarizes the worst case over the dispensing and all follow-up visits.
Lens Centration	Summarized over all follow-up visits through 1 month	Lens centration was assessed as excellent(fully centered), good (slight decentration, no corneal exposure), fair (decentration, intermittent corneal exposure), or poor (incomplete corneal coverage and/or edge lift). Suboptimal lens centration was defined as a rating other than excellent.
Lens Deposits	Summarized over all follow-up visits through one month	Degree of lens deposits was assessed as none, light, medium, or heavy. Suboptimal lens deposits were defined as a degree rating of medium or heavy. Measured over all visits through one month
Symptoms & Complaints	Summarized over all follow-up visits through one month	Subject symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting least favorable symptoms/complaints and 100 being the most favorable score.