We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01192542
First Posted: September 1, 2010
Last Update Posted: June 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
  Purpose
The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days.

Condition Intervention
Myopia Device: galyfilcon A prototype lens Device: enfilcon A lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Dispensing Evaluation of a New Galyfilcon A Prototype and Avaira Lenses

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • Monocular Visual Acuity Assessment [ Time Frame: Post lens insertion (baseline) ]
    Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.

  • Binocular Visual Acuity [ Time Frame: Post lens insertion (baseline) ]
    Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value <0 implies clinically positive results, a value >0 implies clinically negative results


Secondary Outcome Measures:
  • Limbal Redness of Grade 3 or Above [ Time Frame: After 6-8 days of lens wear ]
    Limbal redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with limbal redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.

  • Bulbar Redness of Grade 3 or Above [ Time Frame: After 6-8 days of lens wear ]
    Bulbar redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with bulbar redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.


Enrollment: 39
Study Start Date: August 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
galyfilcon A prototype lens/enfilcon A lens
galyfilcon A prototype contact lens worn daily for 6-8 days first then enfilcon A contact lens worn daily for 6-8 days second.
Device: galyfilcon A prototype lens
Prototype silicone hydrogel contact lens
Device: enfilcon A lens
Marketed silicone hydrogel contact lens
Other Name: Avaira® contact lens
enfilcon A lens/galyfilcon A prototype lens
enfilcon A contact lens worn daily for 6-8 days first then galyfilcon A prototype contact lens worn daily for 6-8 days second.
Device: galyfilcon A prototype lens
Prototype silicone hydrogel contact lens
Device: enfilcon A lens
Marketed silicone hydrogel contact lens
Other Name: Avaira® contact lens

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 this clinical protocol.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192542


Locations
United States, California
Pismo Beach, California, United States
United States, Rhode Island
Warwick, Rhode Island, United States
United States, Virginia
Fincastle, Virginia, United States
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01192542     History of Changes
Other Study ID Numbers: CR-1636BE
First Submitted: August 30, 2010
First Posted: September 1, 2010
Results First Submitted: September 17, 2013
Results First Posted: January 17, 2014
Last Update Posted: June 10, 2016
Last Verified: May 2016