Product Performance of a Daily Disposable Contact Lens

NCT01230554 | Completed Results

• 1 other identifier: 654
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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

Keywords

contact lens

Outcome Measures

Primary Outcomes (1)

• Market Research Survey

  Online subjective assessments that subjects responded to after wearing the study lenses for at least one week. Subjects were asked to rate their overall opinion as: Excellent, Very Good, Good, Fair, or Poor.

  1 week

Secondary Outcomes (3)

• Lens Evaluation - Centration

  Over all study visits through 1 week

• Lens Evaluation - Movement

  Over all study visits through 1 week

• Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA).

  Over all study visits for 1 week

Study Arms (1)

Prism I

EXPERIMENTAL

Bausch \& Lomb daily disposable cosmetic tint contact lens

Device: Daily disposable cosmetic tint lens

Interventions

Daily disposable cosmetic tint lens DEVICE

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

Prism I

Eligibility Criteria

• Age: 15 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb

Singapore, 556741, Singapore

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Robert Steffen
• Organization: Bausch Health Americas, Inc

Robert.Steffen@bausch.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: October 27, 2010
• First Posted: October 29, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 28, 2019
• Results First Posted: August 14, 2019

Record last verified: 2019-08

Locations

SG (1)