Trial Outcomes & Findings for Lens Wearing Experience and Biocompatibility of a Multi-Purpose Disinfecting Solution (MPDS) (NCT NCT01476722)

NCT ID: NCT01476722

Last Updated: 2012-11-19

Results Overview

Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a 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 (\>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 125 participants
• Primary outcome timeframe: Day 0 (Baseline)
• Results posted on: 2012-11-19

Participant Flow

Subjects were recruited from 5 US study centers.

Participant milestones

Measure	OPTI-FREE PureMoist OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
Overall Study STARTED	125
Overall Study COMPLETED	124
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	OPTI-FREE PureMoist OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
Overall Study Adverse Event	1

Baseline Characteristics

Lens Wearing Experience and Biocompatibility of a Multi-Purpose Disinfecting Solution (MPDS)

Baseline characteristics by cohort

Measure	OPTI-FREE PureMoist n=124 Participants OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
Age Continuous	32.2 years STANDARD_DEVIATION 11.39 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment United States	124 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 (Baseline)

Population: Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.

Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a 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 (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.

Outcome measures

Measure	OPTI-FREE PureMoist n=124 Participants OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
Corneal Fluorescein Staining Type at Baseline	1.7 Units on a scale Standard Deviation 1.38

PRIMARY outcome

Timeframe: Day 30

Population: Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.

Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a 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 (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.

Outcome measures

Measure	OPTI-FREE PureMoist n=124 Participants OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
Corneal Fluorescein Staining Type at Day 30	0.7 Units on a scale Standard Deviation 0.94

PRIMARY outcome

Timeframe: Day 0 (Baseline)

Population: Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.

Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.

Outcome measures

Measure	OPTI-FREE PureMoist n=124 Participants OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
Corneal Fluorescein Staining Area at Baseline	5.6 Units on a scale Standard Deviation 9.34

PRIMARY outcome

Timeframe: Day 30

Population: Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.

Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.

Outcome measures

Measure	OPTI-FREE PureMoist n=124 Participants OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
Corneal Fluorescein Staining Area at Day 30	1.4 Units on a scale Standard Deviation 2.41

Adverse Events

OPTI-FREE PureMoist

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.

alcon Blobal Medical Affairs

Phone: 1-888-451-3937

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor 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