OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
Status: | Active, not recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 45 - 65 |
Updated: | 2/2/2017 |
Start Date: | December 16, 2016 |
End Date: | April 3, 2017 |
Clinical Study of OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
The purpose of this study is to evaluate OPTI-FREE® PureMoist® (OFPM) compared to
non-HYDRAGLYDE® multipurpose contact lens solutions in presbyopes currently wearing soft
contact lenses and experiencing symptoms of dryness.
non-HYDRAGLYDE® multipurpose contact lens solutions in presbyopes currently wearing soft
contact lenses and experiencing symptoms of dryness.
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.
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