Status:
COMPLETED
Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric Lenses
Lead Sponsor:
CooperVision, Inc.
Conditions:
Astigmatism
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The aim of this dispensing study is to evaluate the clinical performance of existing wearers of Avaira toric lenses following a refit with Clariti toric over 1 month of daily wear.
Detailed Description
This is a 30-subject, prospective dispensing study comparing the clinical performance of the subjects' habitual Avaira toric lenses following a refit with Clariti toric lenses. Subject's habitual Avai...
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 Avaira toric contact lens (CL) wearer (at least 1 week of wear in Avaira toric)
- Has a contact lens spherical prescription between +6.00 to - 8.00 (inclusive)
- Have no less than 0.75D of astigmatism and no more than 1.75 D 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
- Is not a habitual wearer of Avaira toric lenses
- Has a CL prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder less than -0.75D or more than -1.75 D of cylinder in either eye.
- Has a history of not achieving comfortable 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
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea.
- Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02248766
Start Date
September 1 2014
End Date
October 1 2014
Last Update
August 3 2020
Active Locations (1)
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1
Optometry Research Group (GIO) - Optics Department, University of Valencia
Valencia, Spain