Trial Outcomes & Findings for Comparative Performance of PureVision Lens Designs (NCT NCT00661687)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

206 participants

Primary outcome timeframe

Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits

Results posted on

2011-12-12

Participant Flow

Recruitment began on 12/24/07 and lasted for 1 month. Participants were recruited from 10 Asian Sites.

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.

Participant milestones

Participant milestones
Measure	PureVision Contact Lens 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.
Overall Study STARTED	204
Overall Study COMPLETED	189
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	PureVision Contact Lens 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.
Overall Study Study related symptoms and complaints	5
Overall Study Positive slit lamp findings	4
Overall Study Inability to maintain wearing schedule	3
Overall Study Physician Decision	1
Overall Study Adverse Event	2

Baseline Characteristics

Comparative Performance of PureVision Lens Designs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PureVision Contact Lens n=204 Participants PureVision Contact Lens Original Design and New Design.
Age Continuous	28.1 Years STANDARD_DEVIATION 6.97 • n=5 Participants
Sex: Female, Male Female	130 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants
Race/Ethnicity, Customized Asian	203 Participants n=5 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits

Population: All eligible participants

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.

Outcome measures

Outcome measures
Measure	PureVision Contact Lens Design #1 n=204 eyes PureVision soft contact lens (currently marketed).	PureVision Contact Lens Design #2 n=204 eyes Redesign of the currently marketed PureVision soft contact lens.
Subjective Responses to Symptoms/Complaints	80.0 Visual Analogue Scale Standard Deviation 15.07	81.2 Visual Analogue Scale Standard Deviation 14.52

SECONDARY outcome

Timeframe: Mean over all visits - 1 day, 1 week, 1 month

Population: All Eligible, Dispensed Eyes

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.

Outcome measures

Outcome measures
Measure	PureVision Contact Lens Design #1 n=204 eyes PureVision soft contact lens (currently marketed).	PureVision Contact Lens Design #2 n=204 eyes Redesign of the currently marketed PureVision soft contact lens.
LogMAR Visual Acuity	0.001 LogMAR Standard Deviation 0.0678	0.003 LogMAR Standard Deviation 0.0673

SECONDARY outcome

Timeframe: Over all scheduled visits day 1 - 1 month

Population: Over All Scheduled Visits, All Eligible, Dispensed Eyes

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.

Outcome measures

Outcome measures
Measure	PureVision Contact Lens Design #1 n=204 eyes PureVision soft contact lens (currently marketed).	PureVision Contact Lens Design #2 n=204 eyes Redesign of the currently marketed PureVision soft contact lens.
Lens Characteristics Lens wettability - 100% of anterior surface	75 Eyes	78 Eyes
Lens Characteristics Lens discoloration - absent	182 Eyes	182 Eyes
Lens Characteristics Suboptimal lens deposits (medium/heavy) - absent	181 Eyes	179 Eyes
Lens Characteristics Lens centration - excellent	171 Eyes	164 Eyes
Lens Characteristics Lens movement - adequate	138 Eyes	138 Eyes

Adverse Events

PureVision Contact Lens Design #1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PureVision Contact Lens Design #2

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
Publication restrictions are in place

Restriction type: LTE60