Product Performance of a Daily Disposable Contact Lens

NCT ID: NCT01230554

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2010-11-30

Brief Summary

The objective of this one week, single group, bilateral, open-label study is to evaluate the product performance of the Bausch & Lomb daily disposable cosmetic tint contact lens (Test) when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted soft contact lens.

Conditions

Myopia

Study Design

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

Study Groups

Prism I

Bausch \& Lomb daily disposable cosmetic tint contact lens

Group Type: EXPERIMENTAL

Daily disposable cosmetic tint lens

Intervention Type: DEVICE

Bausch \& Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.

Interventions

Daily disposable cosmetic tint lens

Bausch \& Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects must be females of Chinese descent and of legal age and no older than 38. OR subjects that are females of Chinese descent and are at least 15 years of age and less than the legal age must: have a parent/legal guardian provide informed consent.
• Subjects must have clear central corneas and be free of any anterior segment disorders.
• Subjects must be adapted current wearers of marketed opaque tinted soft contact lenses, wear their lenses two days or more per week, and wear a lens in each eye.

Exclusion Criteria

• Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or have worn polymethylmethacrylate (PMMA) lenses within the last three months.
• 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 scar or neovascularization within the central 4 mm of the cornea.
• Subjects who are aphakic or amblyopic.
• Subjects who have had any corneal surgery (eg, refractive surgery).
• Subjects who currently wear monovision, multifocal, or toric contact lenses.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bausch & Lomb

Singapore, , Singapore

Countries

Singapore

Other Identifiers

654

Identifier Type: -

Identifier Source: org_study_id