OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate OPTI-FREE® PureMoist® (OFPM) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.

Official Title
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Clinical Study of OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Opti-Free® PureMoist® contact lens solution
* Device: Habitual Multi-Purpose Contact Lens Solution
* Device: Habitual Contact Lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must sign an informed consent document; Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness; Near spectacle add of +0.50 or greater; Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance; Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits; Currently using a non-Alcon multi-purpose solution to care for lenses (at least 2 months); Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study; Other protocol-specific inclusion criteria may apply. Exclusion Criteria: Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week); Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator; Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear; Monocular (only 1 eye with functional vision) or fit with only 1 lens; Known sensitivity to any ingredients in OFPM; Prior refractive surgery; History of herpetic keratitis, ocular surgery, or irregular cornea; Pathological dry eye that precludes contact lens wear; Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study; Participation in any clinical study within 30 days of Visit 1; Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days; Other protocol-specific exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: OFPM, then HMPS<br>OPTI-FREE® PureMoist® multi-purpose contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles. | Device: Opti-Free® PureMoist® contact lens solution<br> <br> * Other names: OPTI-FREE® PureMoist®;Device: Habitual Multi-Purpose Contact Lens Solution<br> <br> Device: Habitual Contact Lenses<br>* Subject's habitual contact lens brand worn in a daily wear modality for 30 days.<br>|
| Other: HMPS, then OFPM<br>Subject's habitual multi-purpose contact lens solution in Period1, followed by OPTI-FREE® PureMoist® contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles. | Device: Opti-Free® PureMoist® contact lens solution<br> <br> * Other names: OPTI-FREE® PureMoist®;Device: Habitual Multi-Purpose Contact Lens Solution<br> <br> Device: Habitual Contact Lenses<br>* Subject's habitual contact lens brand worn in a daily wear modality for 30 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30 | CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms. | Day 30, each product | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lens induced dryness