N/A
N=30
Clinical Performance of Existing Wearers of Avaira Sphere Following a Refit With Clariti Elite Sphere
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT02248727 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Visual Acuity - Enfilcon A and Somofilcon A — -0.037; -0.037; -0.037; -0.037 logMar
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- somofilcon A (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity - Enfilcon A and Somofilcon A |
-0.037; -0.037; -0.037; -0.037; -0.037; -0.037 | — |
| PRIMARY Subjective Assessments. - Enfilcon A and Somofilcon A |
8.43; 7.73; 7.33; 6.80; 8.53; 7.20 | — |
Summary
The aim of this dispensing study is to evaluate the clinical performance of existing wearers of Avaira sphere lenses following a refit with Clariti Elite sphere over 4 weeks of daily wear.
Eligibility Criteria
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 sphere contact lens (CL) wearer (at least 1 week in Avaira sphere)
- Has a contact lens spherical prescription between -1.00 to - 6.00 (inclusive)
- Has a spectacle cylinder up to 0.75D in each eye.
- 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 sphere lenses
- Has a contact lens prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder ≥1.00D 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.
Data sourced from ClinicalTrials.gov (NCT02248727). 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.