Trial Outcomes & Findings for Evaluation of the Performance of Non-molded Soft Contact Lenses (NCT NCT00371787)

Results Overview

level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

38 participants

Primary outcome timeframe

baseline

Results posted on

2011-01-10

Participant Flow

Participants recruited from local communities in Kitchener-Waterloo, Canada between July 2006 and Feb 2007

38 participants recruited and screened; 4 withdrew by subject

Participant milestones

Participant milestones
Measure	Treatment Group soft lens wearers with sign of hypoxia and high prescription	Control Group normal non-lens wearers
Overall Study STARTED	26	12
Overall Study COMPLETED	23	11
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Group soft lens wearers with sign of hypoxia and high prescription	Control Group normal non-lens wearers
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Evaluation of the Performance of Non-molded Soft Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=26 Participants soft lens wearers with sign of hypoxia and high prescription	Control Group n=12 Participants normal non-lens wearers	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	12 Participants n=7 Participants	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	31.6 years STANDARD_DEVIATION 10.75 • n=5 Participants	33.25 years STANDARD_DEVIATION 6.9 • n=7 Participants	32.4 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	8 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment Canada	26 participants n=5 Participants	12 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

Population: Per Protocol. Only the data from participants who completed all study visits were analyzed.

level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.

Outcome measures

Outcome measures
Measure	Treatment Group n=26 Participants soft lens wearers with sign of hypoxia and high prescription	Control Group n=12 Participants normal non-lens wearers
Visual Acuity	0.01 logMAR Standard Deviation 0.09	-0.07 logMAR Standard Deviation 0.11

PRIMARY outcome

Timeframe: 9 month

level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.

Outcome measures

Outcome measures
Measure	Treatment Group n=26 Participants soft lens wearers with sign of hypoxia and high prescription	Control Group n=12 Participants normal non-lens wearers
Visual Acuity	0.01 logMAR Standard Deviation 0.09	-0.08 logMAR Standard Deviation 0.10

PRIMARY outcome

Timeframe: baseline

length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.

Outcome measures

Outcome measures
Measure	Treatment Group n=26 Participants soft lens wearers with sign of hypoxia and high prescription	Control Group n=12 Participants normal non-lens wearers
Neovascularisation	0.84 mm Standard Deviation 0.39	0.35 mm Standard Deviation 0.16

PRIMARY outcome

Timeframe: 9 month

length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.

Outcome measures

Outcome measures
Measure	Treatment Group n=26 Participants soft lens wearers with sign of hypoxia and high prescription	Control Group n=12 Participants normal non-lens wearers
Neovascularization	0.63 mm Standard Deviation 0.2	0.35 mm Standard Deviation 0.19

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

Dr. Craig Woods

Centre for Contact Lens Research

Phone: 1-519-888-4567

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place