Product Performance of a Daily Disposable Contact Lens

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01230554
• Collaborator: (none)
• Enrollment: 212
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 70.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Daily disposable cosmetic tint lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 212 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Study to Assess the Product Performance of a Daily Disposable Contact Lens
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Market Research Survey [1 week]

   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

1. Lens Evaluation - Centration [Over all study visits through 1 week]

   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.

2. Lens Evaluation - Movement [Over all study visits through 1 week]

   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.

3. Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA). [Over all study visits for 1 week]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 38 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb	Singapore		Singapore	556741

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01230554
• Other Study ID Numbers: 654
• First Posted: Oct 29, 2010
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Bausch & Lomb Incorporated: contact lens
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Prism I
Arm/Group Description	Bausch & Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Period Title: Overall Study
STARTED	212
COMPLETED	209
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Prism I
Arm/Group Description	Bausch & Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Overall Participants	212
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.0 (5.2)
Sex: Female, Male (Count of Participants)
Female	212 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects who completed the survey.

Arm/Group Title	Prism I
Arm/Group Description	Bausch & Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Measure Participants	210
Excellent	10 4.7%
Very Good	91 42.9%
Good	93 43.9%
Fair	16 7.5%
Poor	0 0%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Eligible, dispense eyes with non-missing scores.

Arm/Group Title	Prism I
Arm/Group Description	Bausch & Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Measure Participants	212
Measure eyes	424
Excellent	287
Good	109
Fair	14
Poor	14

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Eligible, dispense eyes with non-missing scores.

Arm/Group Title	Prism I
Arm/Group Description	Bausch & Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Measure Participants	212
Measure eyes	424
Adequate	246
Excessive	0
Insufficient	168
Adherence	10

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Eyes with VA results

Arm/Group Title	Prism I
Arm/Group Description	Bausch & Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Measure Participants	212
Measure eyes	424
Mean (Standard Error) [logMAR]	0.012 (0.070)

Adverse Events

Time Frame	Up to 1 week
Adverse Event Reporting Description	Adverse events were collected throughout the study.
Arm/Group Title	Prism I
Arm/Group Description	Bausch & Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
All Cause Mortality
	Prism I
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Prism I
	Affected / at Risk (%)	# Events
Total	0/212 (0%)
Other (Not Including Serious) Adverse Events
	Prism I
	Affected / at Risk (%)	# Events
Total	0/212 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.