N/A
N=61
Evaluation of Comfilcon A and Senofilcon A Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01695369 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Subjective Responses for Comfort Rated on a 0-100 Visual Scale. — 86; 87; 89; 91 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Senofilcon A; Comfilcon A (Device); Comfilcon A; Senofilcon A (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Responses for Comfort Rated on a 0-100 Visual Scale. |
86; 87; 89; 91; 83; 84 | — |
Summary
Evaluation of Comfilcon A and Senofilcon A Lenses
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01695369). 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.