Status:
COMPLETED
Clinical Performance of Stenfilcon A Versus Filcon II 3
Lead Sponsor:
CooperVision, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Clinical Performance of Stenfilcon vs. Filcon II 3
Detailed Description
The objective of this study is to compare the comfort and clinical performance of Stenfilcon vs. Filcon II 3 compared to subject's habitual contact lenses. The null hypothesis is that there is no diff...
Eligibility Criteria
Inclusion
- Subjects must satisfy the following conditions prior to inclusion in the study:
- Based on his/her knowledge, must be in good general health. Be of legal age (18 years) or older.
- Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
- Read, indicate understanding of, and sign Written Informed Consent (Appendix 1)
- Require a contact lens prescription between -0.50 and -6.00 and have no more than -.75dioptor (D) of astigmatism in both eyes
- Achieve visual acuity of 6/9 or better in each eye with a spherical contact lens prescription.
- An existing soft contact lens wearer of any modality.
- Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so.
- 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 greater than Grade 2: 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
Exclusion
- Any of the following will render a subject ineligible for inclusion:
- Neophytes, who have not worn lenses before
- Greater than 0.75D of refractive astigmatism in either eye
- Presence of clinically significant (grade 3 or above) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
- Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
- Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium, pinguecula or corneal scars within the visual axis
- Neovascularization \> 0.75 mm in from the limbus
- Giant papillary conjunctivitis (GPC) Grade 3 or above
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, seborrheic conjunctivitis
- History of corneal ulcer or fungal infections
- Poor personal hygiene
- A known history of corneal hypoesthesia (reduced corneal sensitivity).
- Contact lens best corrected Snellen visual acuities (VA) worse than 6/9
- Aphakia, Keratoconus or a highly irregular cornea
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01808209
Start Date
January 1 2013
End Date
May 1 2013
Last Update
August 3 2020
Active Locations (1)
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1
University of Aston
Birmingham, West Midlands, United Kingdom, B4 7ET