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N/A N=61 Randomized Single-blind Other

Evaluation of Comfilcon A and Senofilcon A Lenses

Myopia

Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Subjective Responses for Comfort Rated on a 0-100 Visual Scale. — 86; 87; 89; 91 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Senofilcon A; Comfilcon A (Device); Comfilcon A; Senofilcon A (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
CooperVision, Inc.
Primary completion
Aug 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Subjective Responses for Comfort Rated on a 0-100 Visual Scale.
86; 87; 89; 91; 83; 84

Summary

Evaluation of Comfilcon A and Senofilcon A Lenses

Eligibility Criteria

Inclusion Criteria

Subjects must satisfy the following conditions prior to inclusion in the study:

  • Has had an oculo-visual examination in the last two years
  • Is at least 18 years of age and has full legal capacity to volunteer
  • Has read and understood the information consent letter
  • Is willing and able to follow instructions and maintain the appointment schedule
  • Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
  • Currently wears soft contact lenses at least 3 days a week, 8 hours a day
  • Has clear corneas and no active ocular disease
  • Has not worn lenses for at least 12 hours before the examination
  • Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
  • No amblyopia
  • No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes)
  • No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
  • No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
  • No aphakia
  • Has prescription to match the available power range.

Exclusion Criteria

Any of the following will render a subject ineligible for inclusion:

  • Greater than 0.75 of refractive astigmatism in either eye
  • Has never worn contact lenses before
  • Wears contact lenses on an extended wear basis
  • Has any systemic disease affecting ocular health
  • Is a known sufferer of ocular allergies
  • Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
  • Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
  • Is aphakic
  • Has undergone corneal refractive surgery.
  • Is wearing monovision
  • Is participating in any other type of clinical or research study
  • Female who is currently pregnant or is breast-feeding
  • Has > grade 1 ocular corneal staining in both type and extent by > grade 2 in either type or extent
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01695369). 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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