Clinical trial NCT01130974: A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens
Official title: A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Slit Lamp Findings
timeFrame: Summarized over all follow-up visits through 1 month
measure: logMAR Visual Acuity (VA)
timeFrame: Summarized over all visits, and dispensed visit
measure: logMAR Visual Acuity (VA)
timeFrame: 2 week and 1 month follow-up
Secondary outcomes:
measure: Lens Wettability
timeFrame: Summarized over all follow-up visits through 1 month
measure: Lens Deposits
timeFrame: Summarized over all follow-up visits through one month
measure: Lens Centration
timeFrame: Summarized over all follow-up visits through 1 month
measure: Lens Movement
timeFrame: Summarized over all follow-up visits through one month
measure: Symptoms & Complaints
timeFrame: Summarized over all follow-up visits through one month
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Bev Barna
role: STUDY_DIRECTOR
References: