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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01476722
• Collaborator: (none)
• Enrollment: 125
• Location: 1
• Arm: 1
• Duration (Months): 4
• Patients Per Site Per Month: 31.2

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the efficacy of a new multipurpose disinfecting solution in silicone hydrogel and soft contact lens wearers.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: OPTI-FREE PureMoist multipurpose disinfecting solution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 125 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Lens Wearing Experience and Biocompatibility With OPTI-FREE® PureMoist® Multi-Purpose Disinfecting Solution (OFP MPDS) in Silicone Hydrogel and Soft Contact Lens Wearers (US)
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OPTI-FREE PureMoist OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days	Device: OPTI-FREE PureMoist multipurpose disinfecting solution; FDA-approved, multipurpose disinfecting solution used as indicated for cleaning, rinsing, reconditioning, disinfecting, and storing silicone hydrogel and soft contact lenses on a daily wear basis for 30 days

Outcome Measures

Primary Outcome Measures

1. Corneal Fluorescein Staining Type at Baseline [Day 0 (Baseline)]

   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.

2. Corneal Fluorescein Staining Type at Day 30 [Day 30]

   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.

3. Corneal Fluorescein Staining Area at Baseline [Day 0 (Baseline)]

   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.

4. Corneal Fluorescein Staining Area at Day 30 [Day 30]

   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.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Wear silicone hydrogel or traditional soft contact lenses on a daily wear basis, (a minimum of 8 hours per day) for at least one month prior to Visit 1;

• Habitual use of a multi-purpose solution containing PHMB for at least 30 days prior to Visit 1;

• Vision correctable to 20/30 (Snellen) or better in each eye at distance with pre-study lenses at Visit 1;

• Read, sign, and date IRB-approved informed consent and privacy document;

• Be generally healthy and have normal ocular health;

• Willing to follow the study procedures and visit schedule;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Wear lenses on an extended wear basis during the study;

• Known sensitivity or intolerance to PHMB, POLYQUAD, or ALDOX preserved lens care products;

• Monocular subject;

• Requirestoric or multifocal contact lenses;

• Use of additional lens care products other than a PHMB multi-purpose solution such as daily or enzyme cleaners within the one week prior to Visit 1;

• Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;

• Any abnormal ocular condition observed during the Visit 1 Slit-lamp examination;

• Ocular surgery within the 12 months prior to Visit 1;

• Use of any systemic medication which has known or expected ocular or systemic side effects at Visit 1, that in the clinical judgment of the investigator, could affect the subject's participation in this study;

• Any systemic disease at Visit 1 that may affect the eye or be exacerabated by use of contact lenses or contact lens solutions or which could prevent subjects from wearing their lenses at least 8 hours per day;

• Participation in any clinical study within 30 days of Visit 1;

• 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	76314

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01476722
• Other Study ID Numbers: RDG-11-149
• First Posted: Nov 22, 2011
• Last Update Posted: Nov 19, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Alcon Research: Silicone Hydrogel; Soft Contact Lenses; Multi-Purpose Solution

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 5 US study centers.

Arm/Group Title	OPTI-FREE PureMoist
Arm/Group Description	OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
Period Title: Overall Study
STARTED	125
COMPLETED	124
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	OPTI-FREE PureMoist
Arm/Group Description	OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
Overall Participants	124
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.2 (11.39)
Sex: Female, Male (Count of Participants)
Female	89 71.8%
Male	35 28.2%
Region of Enrollment (participants) [Number]
United States	124 100%

Outcome Measures

1. Primary Outcome

Title	Corneal Fluorescein Staining Type at Baseline
Description	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.
Time Frame	Day 0 (Baseline)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	OPTI-FREE PureMoist
Arm/Group Description	OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
Measure Participants	124
Mean (Standard Deviation) [Units on a scale]	1.7 (1.38)

2. Primary Outcome

Title	Corneal Fluorescein Staining Type at Day 30
Description	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.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	OPTI-FREE PureMoist
Arm/Group Description	OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
Measure Participants	124
Mean (Standard Deviation) [Units on a scale]	0.7 (0.94)

3. Primary Outcome

Title	Corneal Fluorescein Staining Area at Baseline
Description	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.
Time Frame	Day 0 (Baseline)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	OPTI-FREE PureMoist
Arm/Group Description	OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
Measure Participants	124
Mean (Standard Deviation) [Units on a scale]	5.6 (9.34)

4. Primary Outcome

Title	Corneal Fluorescein Staining Area at Day 30
Description	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.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	OPTI-FREE PureMoist
Arm/Group Description	OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
Measure Participants	124
Mean (Standard Deviation) [Units on a scale]	1.4 (2.41)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study (e.g., 4 months).
Adverse Event Reporting Description	The safety population includes all enrolled and exposed subjects. Both volunteered and elicited adverse events were collected, monitored, and evaluated through the study.
Arm/Group Title	OPTI-FREE PureMoist
Arm/Group Description	OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
All Cause Mortality
	OPTI-FREE PureMoist
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	OPTI-FREE PureMoist
	Affected / at Risk (%)	# Events
Total	0/125 (0%)
Other (Not Including Serious) Adverse Events
	OPTI-FREE PureMoist
	Affected / at Risk (%)	# Events
Total	0/125 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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