Comparative Performance of PureVision Lens Designs

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00661687
• Collaborator: (none)
• Enrollment: 206
• Locations: 2
• Arms: 2
• Duration (Months): 6
• Patients Per Site: 103
• Patients Per Site Per Month: 17.1

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Currently Marketed PureVision Contact Lens.; Device: Alternate Design of the PureVision Contact Lens.	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 206 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Study to Evaluate the Product Performance of the Redesigned Bausch & Lomb PureVision® Contact Lens (Test) Compared to the Currently Marketed Bausch & Lomb PureVision® Contact Lens (Control) When Worn on an Extended Wear Basis.
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Purevision Contact Lens #1 PureVision Soft Contact Lens Design (currently marketed)	Device: Currently Marketed PureVision Contact Lens.; Contact lens for continuous wear
Experimental: PureVision Contact Lens #2 Redesign of the currently marketed PureVision soft contact lens.	Device: Alternate Design of the PureVision Contact Lens.; Contact lens for continuous wear

Outcome Measures

Primary Outcome Measures

1. Subjective Responses to Symptoms/Complaints [Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits]

   Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.

Secondary Outcome Measures

1. LogMAR Visual Acuity [Mean over all visits - 1 day, 1 week, 1 month]

   The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.

2. Lens Characteristics [Over all scheduled visits day 1 - 1 month]

   Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• subject is myopic

• VA correctable to 0.3 logMAR or better (driving vision)

• Clear central cornea

Exclusion Criteria:

• Systemic disease affecting ocular health

• using systemic or topical medications

• wear monovision, multifocal or toric contact lenses

• Any grade 2 or greater slit lamp findings

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laser Focus Sdn Bhd, Vision Correction Centre	Johor Bahru		Malaysia	80400
2	Asian Eye Institute	Makati City		Philippines	1200

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Gerard Cairns, MCOptom, PhD, Bausch & Lomb Incorporated
• Principal Investigator: Benny Chian, MCOptom, Laser Focus Sdn Bhd, Vision Correction Centre
• Principal Investigator: Harvey Siy Uy, MD, Asian Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00661687
• Other Study ID Numbers: 544
• First Posted: Apr 18, 2008
• Last Update Posted: Dec 12, 2011
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Recruitment began on 12/24/07 and lasted for 1 month. Participants were recruited from 10 Asian Sites.
Pre-assignment Detail	206 participants were enrolled. 204 participants were eligible and 189 completed the study. Study was a contralateral design with one eye of each patient randomly assigned to the experimental group and fellow eye to the control group.

Arm/Group Title	PureVision Contact Lens
Arm/Group Description	PureVision Contact Lens, Original Design and Alternate Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye.
Period Title: Overall Study
STARTED	204
COMPLETED	189
NOT COMPLETED	15

Baseline Characteristics

Arm/Group Title	PureVision Contact Lens
Arm/Group Description	PureVision Contact Lens Original Design and New Design.
Overall Participants	204
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	28.1 (6.97)
Sex: Female, Male (Count of Participants)
Female	130 63.7%
Male	74 36.3%
Race/Ethnicity, Customized (Number) [Number]
Asian	203 99.5%
White	1 0.5%

Outcome Measures

1. Primary Outcome

Title	Subjective Responses to Symptoms/Complaints
Description	Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.
Time Frame	Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits

Outcome Measure Data

Analysis Population Description

All eligible participants

Arm/Group Title	PureVision Contact Lens Design #1	PureVision Contact Lens Design #2
Arm/Group Description	PureVision soft contact lens (currently marketed).	Redesign of the currently marketed PureVision soft contact lens.
Measure Participants	102	102
Measure eyes	204	204
Mean (Standard Deviation) [Visual Analogue Scale]	80.0 (15.07)	81.2 (14.52)

2. Secondary Outcome

Title	LogMAR Visual Acuity
Description	The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.
Time Frame	Mean over all visits - 1 day, 1 week, 1 month

Outcome Measure Data

Analysis Population Description

All Eligible, Dispensed Eyes

Arm/Group Title	PureVision Contact Lens Design #1	PureVision Contact Lens Design #2
Arm/Group Description	PureVision soft contact lens (currently marketed).	Redesign of the currently marketed PureVision soft contact lens.
Measure Participants	102	102
Measure eyes	204	204
Mean (Standard Deviation) [LogMAR]	0.001 (0.0678)	0.003 (0.0673)

3. Secondary Outcome

Title	Lens Characteristics
Description	Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.
Time Frame	Over all scheduled visits day 1 - 1 month

Outcome Measure Data

Analysis Population Description

Over All Scheduled Visits, All Eligible, Dispensed Eyes

Arm/Group Title	PureVision Contact Lens Design #1	PureVision Contact Lens Design #2
Arm/Group Description	PureVision soft contact lens (currently marketed).	Redesign of the currently marketed PureVision soft contact lens.
Measure Participants	102	102
Measure eyes	204	204
Lens wettability - 100% of anterior surface	75	78
Lens discoloration - absent	182	182
Suboptimal lens deposits (medium/heavy) - absent	181	179
Lens centration - excellent	171	164
Lens movement - adequate	138	138

Adverse Events

Time Frame	1 month
Arm/Group Title	PureVision Contact Lens Design #1		PureVision Contact Lens Design #2
Arm/Group Description	PureVision Contact Lens, Original Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye.		PureVision Contact Lens Test Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye
All Cause Mortality
	PureVision Contact Lens Design #1		PureVision Contact Lens Design #2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	PureVision Contact Lens Design #1		PureVision Contact Lens Design #2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/204 (0%)		0/204 (0%)
Other (Not Including Serious) Adverse Events
	PureVision Contact Lens Design #1		PureVision Contact Lens Design #2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/204 (0%)		0/204 (0%)

Limitations/Caveats

2 participants discontinued due to adverse events, not classified as serious. One subject in the test group developed corneal ulcer, one subject in the control group developed a central epithelial defect, both conditions resolved following treatment.

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.