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Trial Outcomes & Findings for Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers (NCT NCT00985231)

NCT ID: NCT00985231

Last Updated: 2015-03-24

Results Overview

Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

272 participants

Primary outcome timeframe

2 weeks

Results posted on

2015-03-24

Participant Flow

This study was conducted at 25 sites, by 25 Investigators in the United States (US). First participant enrollment was 09/28/2009 and last participant exited the study 11/09/2009

272 participants (544 eyes) were enrolled in the study, 7 participants were ineligible at baseline, 265 participants were eligible. 259 participants (518 eyes) completed the study.

Participant milestones

Participant milestones
Measure
PureVision Multi-Focal Contact Lenses
SofLens59 Contact Lens
Overall Study
STARTED
133
132
Overall Study
COMPLETED
130
129
Overall Study
NOT COMPLETED
3
3

Reasons for withdrawal

Reasons for withdrawal
Measure
PureVision Multi-Focal Contact Lenses
SofLens59 Contact Lens
Overall Study
ineligible
1
0
Overall Study
Protocol Violation
1
0
Overall Study
Withdrawal by Subject
1
0
Overall Study
Lost to Follow-up
0
1
Overall Study
Study related symptoms & complaints
0
2

Baseline Characteristics

Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PureVision Multi-Focal Contact Lenses
n=133 Participants
SofLens59 Contact Lens
n=132 Participants
Total
n=265 Participants
Total of all reporting groups
Age, Customized
30-35 years of age
68 participants
n=5 Participants
67 participants
n=7 Participants
135 participants
n=5 Participants
Age, Customized
36 -40 years of age
65 participants
n=5 Participants
65 participants
n=7 Participants
130 participants
n=5 Participants
Sex: Female, Male
Female
114 Participants
n=5 Participants
97 Participants
n=7 Participants
211 Participants
n=5 Participants
Sex: Female, Male
Male
19 Participants
n=5 Participants
35 Participants
n=7 Participants
54 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Asian
7 Participants
n=5 Participants
11 Participants
n=7 Participants
18 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
15 Participants
n=5 Participants
14 Participants
n=7 Participants
29 Participants
n=5 Participants
Race (NIH/OMB)
White
110 Participants
n=5 Participants
104 Participants
n=7 Participants
214 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
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: All Eligible, Dispensed Eyes with non-missing scores

Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.

Outcome measures

Outcome measures
Measure
PureVision Multi-Focal Contact Lenses
n=260 eyes
SofLens59 Contact Lens
n=257 eyes
Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.
2 eyes
0 eyes

SECONDARY outcome

Timeframe: 2 week visit

Population: All Eligible, Dispensed Eyes, CISS Composite Score

Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always

Outcome measures

Outcome measures
Measure
PureVision Multi-Focal Contact Lenses
n=133 Participants
SofLens59 Contact Lens
n=131 Participants
Subjective Ratings of Eye Strain
9.9 CISS Composite Score
Standard Deviation 9.6
9.0 CISS Composite Score
Standard Deviation 9.5

Adverse Events

PureVision Multi-Focal Contact Lenses

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

SofLens59 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

William Reindel, OD, MS

Bausch & Lomb Incorporated

Phone: (585) 338-8129

Results disclosure agreements

  • Principal investigator is a sponsor employee Study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. 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