Trial Outcomes & Findings for Comparative Performance of PureVision, Acuvue Oasys and O2Optix (NCT NCT00640341)

Last Updated: 2011-12-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

510 participants

Primary outcome timeframe

Over all follow-up visits for the 1 month study period

Results posted on

2011-12-12

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	PureVision Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.	Acuvue Oasys Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.	O2Optix Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
Overall Study STARTED	170	170	170
Overall Study Eligible Participants at Baseline	165	167	168
Overall Study COMPLETED	149	165	163
Overall Study NOT COMPLETED	21	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	PureVision Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.	Acuvue Oasys Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.	O2Optix Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
Overall Study Adverse Event	0	0	1
Overall Study Positive Slit Lamp Findings	0	0	1
Overall Study Study Related Symptoms/Complaints	2	1	2
Overall Study Inability to Maintain Wearing Schedule	1	1	0
Overall Study Failure to Follow Subject Instructions	1	0	0
Overall Study Lost to Follow-up	2	0	0
Overall Study Withdrawal by Subject	4	0	1
Overall Study Unacceptable Lens Movement	1	0	0
Overall Study Poor fit/Uncomfortable	4	0	0
Overall Study Ineligable at Baseline	5	3	2
Overall Study Adverse event and positive slit lamp	1	0	0

Baseline Characteristics

Comparative Performance of PureVision, Acuvue Oasys and O2Optix

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PureVision n=165 Participants Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.	Acuvue Oasys n=167 Participants Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.	O2Optix n=168 Participants Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.	Total n=500 Participants Total of all reporting groups
Age, Customized Age 18 to 65 years	165 Participants n=5 Participants	167 Participants n=7 Participants	168 Participants n=5 Participants	500 Participants n=4 Participants
Sex: Female, Male Female	125 Participants n=5 Participants	127 Participants n=7 Participants	124 Participants n=5 Participants	376 Participants n=4 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	40 Participants n=7 Participants	44 Participants n=5 Participants	124 Participants n=4 Participants
Region of Enrollment United States	165 Participants n=5 Participants	167 Participants n=7 Participants	168 Participants n=5 Participants	500 Participants n=4 Participants

PRIMARY outcome

Timeframe: Over all follow-up visits for the 1 month study period

Population: All dispensed eyes

Outcome measures

Outcome measures
Measure	PureVision n=324 eyes Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.	Acuvue Oasys n=338 eyes Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.	O2Optix n=336 eyes Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
Any Slit Lamp Finding > Grade 2	2 Eyes	5 Eyes	10 Eyes

PRIMARY outcome

Timeframe: Over all follow-up visits for 1 month study period

Population: All eligible dispensed eyes.

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.

Outcome measures

Outcome measures
Measure	PureVision n=314 eyes Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.	Acuvue Oasys n=334 eyes Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.	O2Optix n=328 eyes Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
Subjective Responses to Comfort-related Symptoms/Complaints Morning Comfort	85.5 Units on a Scale Standard Deviation 17.55	92.9 Units on a Scale Standard Deviation 11.97	92.0 Units on a Scale Standard Deviation 12.79
Subjective Responses to Comfort-related Symptoms/Complaints Comfort Throughout the Day	82.9 Units on a Scale Standard Deviation 18.94	90.1 Units on a Scale Standard Deviation 14.47	88.4 Units on a Scale Standard Deviation 13.43
Subjective Responses to Comfort-related Symptoms/Complaints End of Day Comfort	76.1 Units on a Scale Standard Deviation 21.86	85.2 Units on a Scale Standard Deviation 16.69	81.4 Units on a Scale Standard Deviation 18.40
Subjective Responses to Comfort-related Symptoms/Complaints Lens Awareness	79.9 Units on a Scale Standard Deviation 23.46	89.5 Units on a Scale Standard Deviation 16.30	86.4 Units on a Scale Standard Deviation 17.91
Subjective Responses to Comfort-related Symptoms/Complaints Irritation	81.7 Units on a Scale Standard Deviation 20.15	90.5 Units on a Scale Standard Deviation 14.42	87.0 Units on a Scale Standard Deviation 15.89
Subjective Responses to Comfort-related Symptoms/Complaints Itching	89.9 Units on a Scale Standard Deviation 15.75	93.5 Units on a Scale Standard Deviation 12.81	92.2 Units on a Scale Standard Deviation 13.57
Subjective Responses to Comfort-related Symptoms/Complaints Dryness	81.9 Units on a Scale Standard Deviation 20.22	89.1 Units on a Scale Standard Deviation 14.42	85.0 Units on a Scale Standard Deviation 17.46
Subjective Responses to Comfort-related Symptoms/Complaints Redness	91.0 Units on a Scale Standard Deviation 14.93	94.5 Units on a Scale Standard Deviation 11.14	91.9 Units on a Scale Standard Deviation 14.23

PRIMARY outcome

Timeframe: Over all visits for the 1 month study period

Population: All eligible dispensed eyes.

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

Outcome measures

Outcome measures
Measure	PureVision n=328 eyes Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.	Acuvue Oasys n=334 eyes Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.	O2Optix n=336 eyes Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
Uncorrected Distance High Contrast Visual Acuity	-0.031 LogMAR Standard Deviation 0.070	-0.026 LogMAR Standard Deviation 0.071	-0.024 LogMAR Standard Deviation 0.0760

Adverse Events

PureVision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acuvue Oasys

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

O2Optix

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gerard Cairns

Bausch & Lomb Incorporated

Phone: (585) 338-5170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER