Evaluation of Comfilcon A and Senofilcon A Lenses
This study has been completed.
Sponsor:
Coopervision, Inc.
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01695369
First received: September 26, 2012
Last updated: April 1, 2013
Last verified: April 2013
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Purpose
Evaluation of two contact lenses
| Condition | Intervention | Phase |
|---|---|---|
|
Myopia |
Device: Senofilcon A; Comfilcon A Device: Comfilcon A; Senofilcon A |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
Further study details as provided by Coopervision, Inc.:
Primary Outcome Measures:
- Patient Reported Outcomes [ Time Frame: Baseline, 5 hours and 10 hours ] [ Designated as safety issue: No ]
| Enrollment: | 61 |
| Study Start Date: | September 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Senofilcon A
Senofilcon A
|
Device: Senofilcon A; Comfilcon A Device: Comfilcon A; Senofilcon A |
|
Experimental: Comfilcon A
Comfilcon A
|
Device: Senofilcon A; Comfilcon A Device: Comfilcon A; Senofilcon A |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects must satisfy the following conditions prior to inclusion in the study:
- Has had an oculo-visual examination in the last two years
- Is at least 18 years of age and has full legal capacity to volunteer
- Has read and understood the information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
- Currently wears soft contact lenses at least 3 days a week, 8 hours a day
- Has clear corneas and no active ocular disease
- Has not worn lenses for at least 12 hours before the examination
- Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- No amblyopia
- No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes)
- No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
- No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
- No aphakia
- Has prescription to match the available power range.
Exclusion Criteria:
- Any of the following will render a subject ineligible for inclusion:
- Greater than 0.75 of refractive astigmatism in either eye
- Has never worn contact lenses before
- Wears contact lenses on an extended wear basis
- Has any systemic disease affecting ocular health
- Is a known sufferer of ocular allergies
- Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
- Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
- Is aphakic
- Has undergone corneal refractive surgery.
- Is wearing monovision
- Is participating in any other type of clinical or research study
- Female who is currently pregnant or is breast-feeding
- Has > grade 1 ocular corneal staining in both type and extent by > grade 2 in either type or extent
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Coopervision, Inc. |
| ClinicalTrials.gov Identifier: | NCT01695369 History of Changes |
| Other Study ID Numbers: | CV-12-54 |
| Study First Received: | September 26, 2012 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 16, 2013