Status:
COMPLETED
Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks
Lead Sponsor:
CooperVision, Inc.
Conditions:
Ametropia
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of daily wear.
Eligibility Criteria
Inclusion
- Is between 18 and 40 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Is an adapted soft contact lens wearer
- Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)
- Have no less than -0.75D (Diopter) of astigmatism in both eyes
- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter
- Patient contact lens refraction should fit within the available parameters of the study lenses
- Is willing to comply with the wear schedule (at least 5 days per week, \>8 hours/day assuming there are no contraindications for doing so)
- Is willing to comply with the visit schedule
Exclusion
- Has a Contact Lens (CL) prescription outside the range of the available parameters of the study lenses
- Has a spectacle cylinder of ≥ 1.00D (Diopter) in either eye
- Has a history of not achieving comfortable Contact Lens (CL) wear (5 days per week; \> 8 hours/day)
- Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye
- Presence of clinically significant (grade 2-4) anterior segment abnormalities
- Presence of ocular or systemic disease or need of medications 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 of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2019
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03835078
Start Date
January 1 2019
End Date
July 6 2019
Last Update
June 11 2020
Active Locations (1)
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1
Optometry Clinic, National Autonomous University
Mexico City, Mexico