Product Performance of a Daily Disposable Contact Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01230554
First received: October 27, 2010
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Myopia
Device: Daily disposable cosmetic tint lens

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Study to Assess the Product Performance of a Daily Disposable Contact Lens

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Market Research Survey [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Online subjective assessments that subjects will respond to after wearing the study lenses for at least one week


Secondary Outcome Measures:
  • Lens Evaluation [ Time Frame: Over all study visits through 1 week ] [ Designated as safety issue: No ]
    Lens centration and lens movement

  • Visual Acuity [ Time Frame: Over all study visits for 1 week ] [ Designated as safety issue: No ]
    logMAR lens visual acuity (VA)


Enrollment: 212
Study Start Date: August 2010
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prism I
Bausch & Lomb daily disposable cosmetic tint contact lens
Device: Daily disposable cosmetic tint lens
Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.

  Eligibility

Ages Eligible for Study:   15 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230554

Locations
Singapore
Bausch & Lomb
Singapore, Singapore, 556741
Sponsors and Collaborators
Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01230554     History of Changes
Other Study ID Numbers: 654
Study First Received: October 27, 2010
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
contact lens

ClinicalTrials.gov processed this record on October 23, 2014