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N/A N=87 Randomized Single-blind Treatment

Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear

Astigmatism

Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Subjective Reported Vision — 0.33; -0.17 Units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
senofilcon A toric (Device); alphafilcon A toric (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Johnson & Johnson Vision Care, Inc.
Primary completion
Dec 2007

Outcome Measures

OutcomeResultp-value
PRIMARY
Subjective Reported Vision
0.33; -0.17
PRIMARY
Subject Reported Lens Comfort.
0.37; -0.38

Summary

The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric contact lens currently available in market, specifically with regards to the comfort and vision after two weeks of use.

Eligibility Criteria

Inclusion Criteria: Prior to being considered eligible to participate in this study, subjects MUST

  • be at least 18 and less than or equal to 39 years of age and have a need for vision correction in BOTH eyes (monovision or uniocular fitting is NOT allowed).
  • be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy.
  • have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study.
  • be able and willing to adhere to the instructions set forth in the protocol.
  • agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
  • have a distance spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes
  • have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
  • be in good general health, based on his/her knowledge.
  • read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT.

Exclusion Criteria

  • The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.
  • The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
  • The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc).
  • Slit lamp findings that would contraindicate contact lens wear such as:
  • Pathological dry eye or associated findings
  • Pterygium or corneal scars within the visual axis
  • Neovascularization >1mm in from the limbus
  • History of giant papillary conjunctivitis (GPC) worse than Grade 2
  • Anterior uveitis or iritis (past or present)
  • Seborrhoeic eczema, seborrhoeic conjunctivitis
  • A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
  • A known history of corneal hypoesthesia (reduced corneal sensitivity.)
  • Aphakia, keratoconus or a highly irregular cornea.
  • Current pregnancy or lactation (to the best of the subject's knowledge).
  • Active participation in another clinical study at any time during this study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00584220). 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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