Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses
Study Details
Study Description
Brief Summary
The study objective was to compare short-term clinical performance data of two soft spherical contact lenses.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Soft Spherical Hydrogel Contact Lens A Subjects will wear Soft Spherical Hydrogel Contact Lens A for the first period of 15 minutes and Soft Spherical Silicone Hydrogel Contact Lens B for the second period of 15 minutes. |
Device: Soft Spherical Hydrogel Contact Lens A
Soft Spherical Hydrogel Contact Lens A - first period of 15 minutes
|
Experimental: Soft Spherical Silicone Hydrogel Contact Lens B Subjects will wear Soft Spherical Silicone Hydrogel Contact Lens B for the second period of 15 minutes. |
Device: Soft Spherical Silicone Hydrogel Contact Lens B
Soft Spherical Silicone Hydrogel Contact Lens B - second period of 15 minutes
|
Outcome Measures
Primary Outcome Measures
- Lens Fit Acceptance Ratings [15 minutes]
Lens Fit Acceptance Ratings will be assessed based on lens fit alone on a scale of 0-4, where 0=Should not be worn, 4=Perfect
Eligibility Criteria
Criteria
Inclusion Criteria:
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Is at least 18 years of age and has full legal capacity to volunteer.
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Has read and signed an information consent letter.
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Self-reports having a full eye examination in the previous two years.
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Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
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Is willing and able to follow instructions and maintain the appointment schedule.
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Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
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Has refractive astigmatism no higher than -0.75DC.
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Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)
Exclusion Criteria:
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Is participating in any concurrent clinical or research study.
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Has any known active ocular disease and/or infection that contraindicates contact lens wear.
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Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
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Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
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Has known sensitivity to the diagnostic sodium fluorescein used in the study.
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Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
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Has undergone refractive error surgery or intraocular surgery.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University Complutense of Madrid | Madrid | Spain | 28037 |
Sponsors and Collaborators
- Coopervision, Inc.
Investigators
- Principal Investigator: Juan G Carracedo RodrÃguez, OD,MSc,PhD, University Complutense of Madrid
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EX-MKTG-142