Phase 3
N=30
Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT00520351 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcome: Primary: High Contrast Visual Acuity — -0.04; -0.04 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ClearCare (Drug); Optifree Replenish (Drug)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- University of Waterloo
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY High Contrast Visual Acuity |
-0.04; -0.04 | — |
| PRIMARY Low Contrast Visual Acuity |
0.26; 0.25 | — |
| PRIMARY In-vivo Wettability |
7.06; 6.54 | — |
| PRIMARY Subjective Comfort Rating |
82.5; 81.3 | — |
Summary
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.
Eligibility Criteria
Inclusion Criteria
A person is eligible for inclusion in the study if he/she:
- Is at least 17 years of age and has full legal capacity to volunteer.
- Has read, understood and signed an information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is presently using either bi-weekly or monthly replacement lenses.
- Has symptoms of ocular dryness as determined by specific pre-screening criteria.
- Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
- Has clear corneas and no active ocular disease.
- Has had an ocular examination in the last two years.
Exclusion Criteria
A person will be excluded from the study if he/she:
- Is an asymptomatic lens wearer.
- Is a daily disposable contact lens wearer.
- Is a current extended wear contact lens wearer.
- Currently uses one of the study lens care regimens.
- Has any clinically significant blepharitis.
- Has undergone corneal refractive surgery.
- Is aphakic.
- Has any active ocular disease.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that may affect ocular health.
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
- Is participating in any other type of clinical or research study.
Data sourced from ClinicalTrials.gov (NCT00520351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.