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N/A N=120 Randomized Single-blind Other

Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

Astigmatism

Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Comfort at Insertion — 8.7; 8.5 units on a scale

Study Design & Population

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Comfort at Insertion
8.1; 8.7
PRIMARY
Comfort at Insertion
8.1; 8.7
PRIMARY
Comfort Preference
25; 35
PRIMARY
Comfort Preference
25; 35

Summary

The purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.

Eligibility Criteria

Inclusion Criteria

  • Based on his/her knowledge, must be in good general health.
  • Be 18 to 38 years old.
  • Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
  • Read, indicate understanding of, and sign Written Informed Consent.
  • Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (Avaira or Oasys) being evaluated in this trial.
  • Require a visual correction in both eyes.
  • Require a prescription between +8.00D and -12.00D and have less than or equal to 0.75D of astigmatism in both eyes.
  • Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
  • 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).
  • 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.

Exclusion Criteria

  • 0.75D or greater of refractive astigmatism in either eye.
  • Presbyopic or current monovision contact lens wear.
  • Cannot be currently wearing either lenses (Avaira or Oasys).
  • Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures.
  • Presence of ocular or systemic disease or need of medication 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 the limbus
  • Giant papillary conjunctivitis (GPC) worse than Grade 1
  • Anterior uveitis or iritis (past or present)
  • Seborrheic eczema, seborrheic conjunctivitis
  • History of corneal ulcer or fungal infections
  • Poor personal hygiene
  • A known history of corneal hypoesthesia (reduced corneal sensitivity)
  • Contact Lens best corrected Snellen visual acuities (VA) worse than 20/30.
  • Aphakia, Keratoconus or a highly irregular cornea.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02356692). 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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