Astigmatism Clinical Trial
Official title:
Clinical Performance of Habitual Wearers of Avaira Toric (Enfilcon A) When Refitted With Clariti Toric (Somofilcon A) Lenses for 1 Month.
NCT number | NCT02248766 |
Other study ID # | EX-MKTG-53 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2014 |
Est. completion date | October 2014 |
Verified date | July 2020 |
Source | Coopervision, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Optometry Research Group (GIO) - Optics Department, University of Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
Coopervision, Inc. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Acuity - Enfilcon A and Somofilcon A | Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. | Baseline, 1 week, 2 week, 4 week | |
Primary | Subjective Assessments- Enfilcon A and Somofilcon A | Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very satisfied) | Baseline, 1 week, 2 week, 4 week |
Status | Clinical Trial | Phase | |
---|---|---|---|
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