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N/A N=491 Randomized Triple-blind Treatment

Vistakon Investigational Contact Lenses Worn for Daily Wear

Myopia

Enrolled (actual)
491
Serious AEs
0.2%
Results posted
May 2016
Primary outcome: Primary: Slit Lamp Findings — 7; 2 Number of Subject Eyes

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
galyifilcon A control lens (Device); galyfilcon A with a silver additive (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johnson & Johnson Vision Care, Inc.
Primary completion
Apr 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Slit Lamp Findings
7; 2
PRIMARY
Subject Reported Symptoms
9.9; 6.3; 4.9; 4.0; 2.8; 2.5
PRIMARY
Visual Acuity
0.004; -0.009
PRIMARY
Average Contact Lens Wear Time
14.0; 14.0

Summary

This study compares the performance of an investigational contact lens to a currently marketed lens.

Eligibility Criteria

Inclusion Criteria

  • The subject must be at least 18 years of age.
  • Both males and females may be enrolled.
  • The subject must read, understand, and sign for themselves the STATEMENT OF INFORMED CONSENT and be provided with a copy of the form.
  • The subject is able and willing to wear soft contact lenses on a daily basis for a six month duration.

Exclusion Criteria

  • The subject must be free of Grade 2 or greater slit lamp findings (edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, and other ocular abnormality), which would contraindicate contact lens wear.
  • Any active ocular (i.e. corneal infiltrates, conjunctiva, lids, and intraocular) infection or inflammation of an allergic, bacterial, or viral etiology.
  • Entropion, ectropion, chalazia, recurrent styes, glaucoma or glaucoma suspect, history of recurrent corneal erosions and aphakia.
  • The following medications are prohibited (at lease one week prior to enrollment): oral retinoid isoretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g. antihistamines (e.g. Seldane, Chlor-Trimeton, and Benadryl), and ophthalmic antihistamic Beta-adrenergic blockers (e.g. Propranolol, Timolol, and Practolol), systemic steroids, and and prescribed or OTC ocular medication. Any prescription or PTC medications or preparations containing silver.
  • Moderate or above corneal distortion by keratometry.
  • Known allergy to silver, silver ions, or silver containing compounds.
  • Abnormal discoloration of the cornea and/or conjunctiva.
  • Routine exposure to silver, silver ions, or silver containing compounds.
  • The subject must be free of systemic diseases which may interfere with contact lens wear: diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases (e.g. AIDS)
  • Free of systemic and infectious diseases: hepatitis and tuberculosis.
  • Subjects must be HIV negative.
  • The subject must not be currently be pregnant or lactating (Subject becoming pregnant during the study will be discontinued).
  • The subject's eyes must be best corrected to a visual acuity of 20/30 or better in each eye.
  • The subject must not have more than 1.00D of refractive astigmatism in either eye.
  • The subject's distance spherical contact lens prescription must be between -1.00D and -6.00D.
  • The subject must not be monovision corrected.
  • The subject must have no history of solution reaction to Opti-free RepleniSH MPDS-No Rub Solution.
  • The subject must not have any previous history or signs of a contact lens related corneal inflammatory event (i.e. past peripheral ulcers or round peripheral scars)
  • The subject must not have participated in a device or pharmaceutical clinical trial within 30 days prior to study enrollment.
  • The subject must not have had an eye injury within 8 weeks prior to study enrollment.
  • The subject must not have had previous eye surgery.
  • The subject must be successfully trial fitted with the study contact lenses.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00717249). 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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