Lens Wearing Experience and Biocompatibility of a Multi-Purpose Disinfecting Solution (MPDS)
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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Fort Worth, Texas, United States, 76314
- Contact Alcon Call Center for Trial Locations
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: OPTI-FREE PureMoist
OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
|
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
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Corneal Fluorescein Staining Type at Baseline
Time Frame: 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.
|
Day 0 (Baseline)
|
|
Corneal Fluorescein Staining Type at Day 30
Time Frame: 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.
|
Day 30
|
|
Corneal Fluorescein Staining Area at Baseline
Time Frame: 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.
|
Day 0 (Baseline)
|
|
Corneal Fluorescein Staining Area at Day 30
Time Frame: 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.
|
Day 30
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- RDG-11-149
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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