Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens

NCT01180985 | Completed Results

• 1 other identifier: CR-1636BD
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.

Conditions

Myopia

Outcome Measures

Primary Outcomes (4)

• Visual Acuity Monocular

  Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.

  after 7 +/- 1 days of lens wear

• Visual Acuity Binocular

  Snellen binocular visual acuity measurement

  after 7 +/- 1 days of lens wear

• Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.

  The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

  after 7 +/-1 days of lens wear

• Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.

  Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

  after 7 +/- 1 days of lens wear

Secondary Outcomes (3)

• Limbal Redness

  after 7 days of lens wear

• Bulbar Redness

  after 7 days of lens wear

• Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.

  10 minutes after lens insertion at time of initial lens fitting

Study Arms (2)

galyfilcon A prototype/comfilcon A

OTHER

The galyfilcon A prototype lenses are worn during first period and comfilcon A lenses worn during second period. Each period consists of daily lens wear for one week.

Device: galyfilcon A prototype lens; Device: comfilcon A

comfilcon A/galyfilcon A prototype

OTHER

The comfilcon A lenses are worn during first period and galyfilcon A prototype lenses worn during second period. Each period consists of daily lens wear for one week.

Device: galyfilcon A prototype lens; Device: comfilcon A

Interventions

galyfilcon A prototype lens DEVICE

silicone hydrogel contact lens

comfilcon A/galyfilcon A prototype; galyfilcon A prototype/comfilcon A

comfilcon A DEVICE

silicone hydrogel contact lens

Also known as: Biofinity® contact lens

comfilcon A/galyfilcon A prototype; galyfilcon A prototype/comfilcon A

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
• The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
• Any cylinder power must be ≤ -0.75D.
• The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
• The subject must read and sign the Statement of Informed Consent.
• The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.

You may not qualify if:

• Ocular or systemic allergies or disease which might interfere with contact lens wear.
• Systemic disease or use of medication which might interfere with contact lens wear.
• Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
• Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Pregnancy or lactation.
• Diabetes.
• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
• Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (4)

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Fincastle, Virginia, United States

Location

Unknown Facility

Salem, Virginia, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: John Buch, OD, MS, FAAO
• Organization: Johnson & Johnson Vision Care

jbuch@its.jnj.com

1 904 443-1707

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 13, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 19, 2018
• Results First Posted: February 5, 2014

Record last verified: 2017-08

Locations

US (4)