Vistakon Investigational Contact Lenses Worn for Daily Wear

NCT00717249 | Completed Results

• 1 other identifier: CR-1513
• Study Type: interventional
• Target: 529
• Locations: 1 country
• Sites: 20

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (4)

• Slit Lamp Findings

  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.

  6 months

• Subject Reported Symptoms

  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.

  6 months

• Visual Acuity

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

  6 months

• Average Contact Lens Wear Time

  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.

  6 Months

Study Arms (2)

Test Lens

EXPERIMENTAL

galyfilcon A contact lens with a silver additive

Device: galyfilcon A with a silver additive

Control Lens

ACTIVE COMPARATOR

galyfilcon A control contact lens

Device: galyifilcon A control lens

Interventions

galyifilcon A control lens DEVICE

Marketed daily wear contact lens

Also known as: ACUVUE Advance with Hydraclear

Control Lens

galyfilcon A with a silver additive DEVICE

Investigational daily wear contact lens

Test Lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (20)

Cole, Cole, and Krohn

Fresno, California, 93704, United States

Location

Dr. James R. Dugue Family Optometrist

Mission Viejo, California, 92691, United States

Location

Fukai and Associates

Louisville, Colorado, 80027, United States

Location

Baymeadows Vision Center

Jacksonville, Florida, 32256, United States

Location

Eyecare Associates

Bloomington, Illinois, 61701, United States

Location

Advantage Eyecare Associates, LLC

Neodesha, Kansas, 66757, United States

Location

InSight Eyecare

Warrensburg, Missouri, 64093, United States

Location

Spectrum Eyecare

Jamestown, New York, 14750, United States

Location

Drs. Quinn, Quinn and Associates

Athens, Ohio, 45701, United States

Location

Dr. Michael H. Greenburg, Inc.

Chagrin Falls, Ohio, 44023, United States

Location

Central Ohio Eyecare

Columbus, Ohio, 43202, United States

Location

James W. Kershaw OD, Inc.

North Olmsted, Ohio, 44070, United States

Location

West Hills Vision Center

Moon Township, Pennsylvania, 15108, United States

Location

Nittany Eye Associates

State College, Pennsylvania, 16801, United States

Location

Research Across America

Wyomissing, Pennsylvania, 19610, United States

Location

Dr. David W. Ferris and Associates

Warwick, Rhode Island, 02886, United States

Location

Premier Vision

Amarillo, Texas, 79119, United States

Location

William J. Bogus OD

Salt Lake City, Utah, 84106, United States

Location

The Eye Speciliasts, Ltd

Virginia Beach, Virginia, 23455, United States

Location

Snowy Range Vision Center

Laramie, Wyoming, 82070, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Brian Pall, O.D., M.S. Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care Inc.

BPALL@its.jnj.com

904-443-3500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 17, 2008
• Study Start: August 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 26, 2016
• Results First Posted: May 26, 2016

Record last verified: 2016-04

Locations

US (20)