Comparative Performance of PureVision, Acuvue Oasys and O2Optix

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00640341
• Collaborator: (none)
• Enrollment: 510
• Location: 1
• Arms: 3
• Duration (Months): 2
• Patients Per Site Per Month: 258.7

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the performance of the PureVision Contact Lens compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily wear basis.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: PureVision Contact Lens; Device: Acuvue Oasys Contact Lens; Device: O2Optix Contact lens	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 510 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Product Performance of Bausch & Lomb PureVision® Contact Lens When Compared to Johnson & Johnson Acuvue Oasys Contact Lens and the Ciba Vision O2Optix Contact Lens Worn Daily.
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PureVision PureVision Contact Lens	Device: PureVision Contact Lens; contact lens for daily wear
Active Comparator: Acuvue Oasys Acuvue Oasys Contact Lens	Device: Acuvue Oasys Contact Lens; contact lens for daily wear
Active Comparator: O2Optix O2Optix Contact Lens	Device: O2Optix Contact lens; contact lens for daily wear

Outcome Measures

Primary Outcome Measures

1. Any Slit Lamp Finding > Grade 2 [Over all follow-up visits for the 1 month study period]

   All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured.

2. Subjective Responses to Comfort-related Symptoms/Complaints [Over all follow-up visits for 1 month study period]

   Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.

3. Uncorrected Distance High Contrast Visual Acuity [Over all visits for the 1 month study period]

   logMAR high contrast visual acuity (VA) over all visits.

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

• Subject uses a lens care system on a regular basis

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	Anderson & Associates	Tampa	Florida	United States	33612

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Gerard Cairns, MCOptom, PhD, Bausch & Lomb Incorporated
• Principal Investigator: Bruce Anderson, OD, Anderson & Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00640341
• Other Study ID Numbers: 552
• First Posted: Mar 21, 2008
• Last Update Posted: Dec 12, 2011
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	546 subjects (1092 eyes) were planned to be enrolled at 26 investigative sites in the US. First subject enrolled on 2/25/2008 and last subject seen was 4/28/2008.
Pre-assignment Detail	510 subjects (1020 eyes) were enrolled (all were dispensed). 477 subjects (954 eyes) completed the study. 10 subjects were ineligible at baseline and 23 were discontinued during the study.

Arm/Group Title	PureVision	Acuvue Oasys	O2Optix
Arm/Group Description	Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.	Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.	Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
Period Title: Overall Study
STARTED	170	170	170
Eligible Participants at Baseline	165	167	168
COMPLETED	149	165	163
NOT COMPLETED	21	5	7

Baseline Characteristics

Arm/Group Title	PureVision	Acuvue Oasys	O2Optix	Total
Arm/Group Description	Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.	Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.	Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.	Total of all reporting groups
Overall Participants	165	167	168	500
Age, Customized (Number) [Number]
Age 18 to 65 years	165 100%	167 100%	168 100%	500 100%
Sex: Female, Male (Count of Participants)
Female	125 75.8%	127 76%	124 73.8%	376 75.2%
Male	40 24.2%	40 24%	44 26.2%	124 24.8%
Region of Enrollment (Number) [Number]
United States	165 100%	167 100%	168 100%	500 100%

Outcome Measures

1. Primary Outcome

Title	Any Slit Lamp Finding > Grade 2
Description	All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured.
Time Frame	Over all follow-up visits for the 1 month study period

Outcome Measure Data

Analysis Population Description

All dispensed eyes

Arm/Group Title	PureVision	Acuvue Oasys	O2Optix
Arm/Group Description	Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.	Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.	Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
Measure Participants	162	169	168
Measure eyes	324	338	336
Number [Eyes]	2	5	10

2. Primary Outcome

Title	Subjective Responses to Comfort-related Symptoms/Complaints
Description	Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.
Time Frame	Over all follow-up visits for 1 month study period

Outcome Measure Data

Analysis Population Description

All eligible dispensed eyes.

Arm/Group Title	PureVision	Acuvue Oasys	O2Optix
Arm/Group Description	Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.	Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.	Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
Measure Participants	157	167	164
Measure eyes	314	334	328
Morning Comfort	85.5 (17.55)	92.9 (11.97)	92.0 (12.79)
Comfort Throughout the Day	82.9 (18.94)	90.1 (14.47)	88.4 (13.43)
End of Day Comfort	76.1 (21.86)	85.2 (16.69)	81.4 (18.40)
Lens Awareness	79.9 (23.46)	89.5 (16.30)	86.4 (17.91)
Irritation	81.7 (20.15)	90.5 (14.42)	87.0 (15.89)
Itching	89.9 (15.75)	93.5 (12.81)	92.2 (13.57)
Dryness	81.9 (20.22)	89.1 (14.42)	85.0 (17.46)
Redness	91.0 (14.93)	94.5 (11.14)	91.9 (14.23)

3. Primary Outcome

Title	Uncorrected Distance High Contrast Visual Acuity
Description	logMAR high contrast visual acuity (VA) over all visits.
Time Frame	Over all visits for the 1 month study period

Outcome Measure Data

Analysis Population Description

All eligible dispensed eyes.

Arm/Group Title	PureVision	Acuvue Oasys	O2Optix
Arm/Group Description	Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.	Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.	Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
Measure Participants	164	167	168
Measure eyes	328	334	336
Mean (Standard Deviation) [LogMAR]	-0.031 (0.070)	-0.026 (0.071)	-0.024 (0.0760)

Adverse Events

Time Frame	1 month
Arm/Group Title	PureVision		Acuvue Oasys		O2Optix
Arm/Group Description	Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.		Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.		Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
All Cause Mortality
	PureVision		Acuvue Oasys		O2Optix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	PureVision		Acuvue Oasys		O2Optix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/340 (0%)		0/340 (0%)		0/340 (0%)
Other (Not Including Serious) Adverse Events
	PureVision		Acuvue Oasys		O2Optix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/340 (0%)		0/340 (0%)		0/340 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The results of the study may be published or presented by the investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.