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N/A N=30 Single-blind Treatment

Clinical Performance of Existing Wearers of Avaira Sphere Following a Refit With Clariti Elite Sphere

Myopia

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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