Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design (NCT NCT01449526)

Last Updated: 2015-02-18

Results Overview

Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months.

Recruitment status

COMPLETED

Study phase

Target enrollment

166 participants

Primary outcome timeframe

4 visits over 3 months

Results posted on

2015-02-18

Participant Flow

This was a three month study enrolling 166 participants from 12 investigative sites in the United States. First participant was enroled on 08/08/2011, and last participant exited the study on 12/08/2011.

166 participants were enrolled in the study with 158 participants completing the study. A minimum of 68 participants were to be of Japanese descent (both maternal and paternal grandparents born in Japan) for submission to the Japanese Regulatory Agency.

Participant milestones

Participant milestones
Measure	B&L Investigational Contact Lens The Bausch + Lomb investigational silicone hydrogel contact lens B\&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.	B&L PureVision Contact Lens The Bausch + Lomb PureVision silicone hydrogel contact lens B\&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.
Overall Study STARTED	83	83
Overall Study COMPLETED	81	77
Overall Study NOT COMPLETED	2	6

Reasons for withdrawal

Reasons for withdrawal
Measure	B&L Investigational Contact Lens The Bausch + Lomb investigational silicone hydrogel contact lens B\&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.	B&L PureVision Contact Lens The Bausch + Lomb PureVision silicone hydrogel contact lens B\&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	1	1
Overall Study Symptoms/complaints	0	1
Overall Study Lack of Motivation	0	1
Overall Study Cannot maintain visits	0	1

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	B&L Investigational Contact Lens n=83 Participants The Bausch + Lomb investigational silicone hydrogel contact lens B\&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.	B&L PureVision Contact Lens n=83 Participants The Bausch + Lomb PureVision silicone hydrogel contact lens B\&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.	Total n=166 Participants Total of all reporting groups
Age, Continuous	29.0 years n=5 Participants	29.0 years n=7 Participants	29.0 years n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	50 Participants n=7 Participants	108 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	33 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	53 Participants n=5 Participants	55 Participants n=7 Participants	108 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	83 participants n=5 Participants	83 participants n=7 Participants	166 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 visits over 3 months

Population: All Eligible, Dispensed Eyes

Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months.

Outcome measures

Outcome measures
Measure	B&L Investigational Contact Lens n=166 Eyes The Bausch + Lomb investigational silicone hydrogel contact lens B\&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.	B&L PureVision Contact Lens n=166 Eyes The Bausch + Lomb PureVision silicone hydrogel contact lens B\&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.
Visual Acuity (VA)	-0.033 LogMAR Standard Deviation 0.054	-0.038 LogMAR Standard Deviation 0.054

SECONDARY outcome

Timeframe: 3 months

Population: Number of dispensed eyes with non-missing scores in each treatment group.

Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses.

Outcome measures

Outcome measures
Measure	B&L Investigational Contact Lens n=164 Eyes The Bausch + Lomb investigational silicone hydrogel contact lens B\&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.	B&L PureVision Contact Lens n=164 Eyes The Bausch + Lomb PureVision silicone hydrogel contact lens B\&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.
Slit Lamp > Grade 2	2 eyes (2 per participant)	5 eyes (2 per participant)

Adverse Events

B&L Investigational Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B&L PureVision Contact Lens

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

Robert Steffen, OD, MS

Bausch & Lomb Incorporated

Phone: 585-338-6399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER