Skip to main content
OpenTrials
Completed

NCT Number: NCT00717249

Vistakon Investigational Contact Lenses Worn for Daily Wear

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cole, Cole, and Krohn, Fresno, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

galyifilcon A control lens

Device

Marketed daily wear contact lens

Other names: ACUVUE Advance with Hydraclear

galyfilcon A with a silver additive

Device

Investigational daily wear contact lens

Primary outcomes

  1. Slit Lamp Findings

    Time frame: 6 months

    Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.

  2. Subject Reported Symptoms

    Time frame: 6 months

    Subjects were asked "Have you experienced any symptoms or problems since your last visit?" at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, "Dryness", "Other", "Cloudy/ Blurry / Hazy", "Irritation / Discomfort". The percentage of each response across all visits was reported.

  3. Visual Acuity

    Time frame: 6 months

    Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.

  4. Average Contact Lens Wear Time

    Time frame: 6 Months

    The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 17, 2008
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.