Clinical trial NCT01476722: Lens Wearing Experience and Biocompatibility of a Multi-Purpose Disinfecting Solution (MPDS)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Silicone Hydrogel
Soft Contact Lenses
Multi-Purpose Solution
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Corneal Fluorescein Staining Type at Baseline
timeFrame: Day 0 (Baseline)
measure: Corneal Fluorescein Staining Type at Day 30
timeFrame: Day 30
measure: Corneal Fluorescein Staining Area at Baseline
timeFrame: Day 0 (Baseline)
measure: Corneal Fluorescein Staining Area at Day 30
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References: