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Product Performance of a Daily Disposable Contact Lens

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Daily disposable cosmetic tint lens
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopia focused on measuring contact lens

Eligibility Criteria

15 Years - 38 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Bausch & Lomb

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prism I

Arm Description

Bausch & Lomb daily disposable cosmetic tint contact lens

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Lens Evaluation - Centration
To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens centration, meaning the lens should provide full corneal coverage, was assessed during the slit lamp evaluation. Findings were reported as: Excellent, Good, Fair, or Poor.
Lens Evaluation - Movement
To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens movement, meaning the lens should provide discernible movement with: Primary gaze blink Upgaze blink Upgaze lag was assessed during the slit lamp evaluation. Findings were reported as: Adequate, Excessive, Insufficient, Adherence.
Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA).
For determination of high contrast VA, the subject was to be seated so that the distance from the subject's eyes to the logMAR chart is 6.5 feet (2.0 meters). The chart should be at eye level for the subject. The logMAR charts have two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity should be measured through the phoropter using the distance refractive correction with the addition of +0.50D to compensate for the reduced test distance of 6.5 feet (2.0 meters).

Full Information

First Posted
October 27, 2010
Last Updated
August 13, 2019
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01230554
Brief Title
Product Performance of a Daily Disposable Contact Lens
Official Title
A Study to Assess the Product Performance of a Daily Disposable Contact Lens
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
contact lens

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prism I
Arm Type
Experimental
Arm Description
Bausch & Lomb daily disposable cosmetic tint contact lens
Intervention Type
Device
Intervention Name(s)
Daily disposable cosmetic tint lens
Intervention Description
Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Primary Outcome Measure Information:
Title
Market Research Survey
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Lens Evaluation - Centration
Description
To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens centration, meaning the lens should provide full corneal coverage, was assessed during the slit lamp evaluation. Findings were reported as: Excellent, Good, Fair, or Poor.
Time Frame
Over all study visits through 1 week
Title
Lens Evaluation - Movement
Description
To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens movement, meaning the lens should provide discernible movement with: Primary gaze blink Upgaze blink Upgaze lag was assessed during the slit lamp evaluation. Findings were reported as: Adequate, Excessive, Insufficient, Adherence.
Time Frame
Over all study visits through 1 week
Title
Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA).
Description
For determination of high contrast VA, the subject was to be seated so that the distance from the subject's eyes to the logMAR chart is 6.5 feet (2.0 meters). The chart should be at eye level for the subject. The logMAR charts have two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity should be measured through the phoropter using the distance refractive correction with the addition of +0.50D to compensate for the reduced test distance of 6.5 feet (2.0 meters).
Time Frame
Over all study visits for 1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Bausch & Lomb
City
Singapore
ZIP/Postal Code
556741
Country
Singapore

12. IPD Sharing Statement

Learn more about this trial

Product Performance of a Daily Disposable Contact Lens

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