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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01192542
First received: August 30, 2010
Last updated: December 16, 2013
Last verified: December 2013
  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: 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 Vistakon:

Primary Outcome Measures:
  • Monocular Visual Acuity Assessment [ Time Frame: Post lens insertion (baseline) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01192542     History of Changes
Other Study ID Numbers: CR-1636BE
Study First Received: August 30, 2010
Results First Received: September 17, 2013
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014