Trial Outcomes & Findings for Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers (NCT NCT01484938)

Results Overview

Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

175 participants

Primary outcome timeframe

Baseline (Day 0), Day 30

Results posted on

2012-10-10

Participant Flow

Participants were recruited from 3 study centers in the Netherlands, 3 study centers in Sweden, and 1 study center in Australia.

Participant milestones

Participant milestones
Measure	OPTI-FREE Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
Overall Study STARTED	175
Overall Study COMPLETED	171
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	OPTI-FREE Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	1
Overall Study Noncompliance	1

Baseline Characteristics

Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OPTI-FREE n=175 Participants Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
Age Continuous	37.6 years STANDARD_DEVIATION 11.66 • n=5 Participants
Sex: Female, Male Female	111 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants
Region of Enrollment Netherlands	72 participants n=5 Participants
Region of Enrollment Sweden	75 participants n=5 Participants
Region of Enrollment Australia	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Day 30

Population: Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses.

Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.

Outcome measures

Outcome measures
Measure	OPTI-FREE n=171 Participants Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30	-5.04 Percentage of corneal staining Standard Deviation 16.119

PRIMARY outcome

Timeframe: Baseline (Day 0), Day 30

Population: Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses.

Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (\>/= 1 mm). The five regions were summed, for a summed total range of 0-20.

Outcome measures

Outcome measures
Measure	OPTI-FREE n=171 Participants Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30	-0.82 Units on a scale Standard Deviation 1.777

Adverse Events

OPTI-FREE

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

Jami Kern, Ph.D., Global Medical Affairs

Alcon Research, Ltd.

Phone: 800-862-5266

Results disclosure agreements

Principal investigator is a sponsor employee Alcon reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER