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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01484938
• Collaborator: (none)
• Enrollment: 175
• Location: 1
• Arm: 1
• Duration (Months): 2.9
• Patients Per Site Per Month: 59.8

Study Details

Study Description

Brief Summary

The purpose of this study was to describe mean differences in corneal staining (type and area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared to Baseline (Day 0).

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: OPTI-FREE PureMoist	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 175 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OPTI-FREE OPTI-FREE PureMoist multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen	Device: OPTI-FREE PureMoist; Commercially marketed multi-purpose contact lens solution for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30 [Baseline (Day 0), Day 30]

   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.

2. Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30 [Baseline (Day 0), Day 30]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years or older

• Soft contact lens wear on a daily wear basis

• Able to wear contact lenses for at least 8 hours

• Generally healthy and have normal ocular health

• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• No use of additional lens cleaners

• No known sensitivities to any ingredient in the test article

• No history of ocular surgery/trauma within the last six months

• Other protocol-defined exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Jami R Kern, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01484938
• Other Study ID Numbers: C-10-017
• First Posted: Dec 5, 2011
• Last Update Posted: Oct 10, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Alcon Research: Soft contact lenses; Multi-purpose solution; Corneal staining
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

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

Arm/Group Title	OPTI-FREE
Arm/Group Description	Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
Period Title: Overall Study
STARTED	175
COMPLETED	171
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	OPTI-FREE
Arm/Group Description	Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
Overall Participants	175
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.6 (11.66)
Sex: Female, Male (Count of Participants)
Female	111 63.4%
Male	64 36.6%
Region of Enrollment (participants) [Number]
Netherlands	72 41.1%
Sweden	75 42.9%
Australia	28 16%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30
Description	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.
Time Frame	Baseline (Day 0), Day 30

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	OPTI-FREE
Arm/Group Description	Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
Measure Participants	171
Mean (Standard Deviation) [Percentage of corneal staining]	-5.04 (16.119)

2. Primary Outcome

Title	Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30
Description	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.
Time Frame	Baseline (Day 0), Day 30

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	OPTI-FREE
Arm/Group Description	Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
Measure Participants	171
Mean (Standard Deviation) [Units on a scale]	-0.82 (1.777)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 3 months, 2 weeks, 2 days.
Adverse Event Reporting Description	All subjects enrolled in the study and exposed to test regimen were evaluable for safety analyses.
Arm/Group Title	OPTI-FREE
Arm/Group Description	Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
All Cause Mortality
	OPTI-FREE
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	OPTI-FREE
	Affected / at Risk (%)	# Events
Total	0/175 (0%)
Other (Not Including Serious) Adverse Events
	OPTI-FREE
	Affected / at Risk (%)	# Events
Total	0/175 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Alcon reserves the right of prior review of any publication or presentation of information related to the study.