search
Back to results

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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
galyfilcon A prototype lens
enfilcon A lens
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopia

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

galyfilcon A prototype lens/enfilcon A lens

enfilcon A lens/galyfilcon A prototype lens

Arm Description

galyfilcon A prototype contact lens worn daily for 6-8 days first then enfilcon A contact lens worn daily for 6-8 days second.

enfilcon A contact lens worn daily for 6-8 days first then galyfilcon A prototype contact lens worn daily for 6-8 days second.

Outcomes

Primary Outcome Measures

Monocular Visual Acuity Assessment
Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.
Binocular Visual Acuity
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
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
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.

Full Information

First Posted
August 30, 2010
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01192542
Brief Title
Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens
Official Title
Dispensing Evaluation of a New Galyfilcon A Prototype and Avaira Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
galyfilcon A prototype lens/enfilcon A lens
Arm Type
Other
Arm Description
galyfilcon A prototype contact lens worn daily for 6-8 days first then enfilcon A contact lens worn daily for 6-8 days second.
Arm Title
enfilcon A lens/galyfilcon A prototype lens
Arm Type
Other
Arm Description
enfilcon A contact lens worn daily for 6-8 days first then galyfilcon A prototype contact lens worn daily for 6-8 days second.
Intervention Type
Device
Intervention Name(s)
galyfilcon A prototype lens
Intervention Description
Prototype silicone hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
enfilcon A lens
Other Intervention Name(s)
Avaira® contact lens
Intervention Description
Marketed silicone hydrogel contact lens
Primary Outcome Measure Information:
Title
Monocular Visual Acuity Assessment
Description
Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.
Time Frame
Post lens insertion (baseline)
Title
Binocular Visual Acuity
Description
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
Time Frame
Post lens insertion (baseline)
Secondary Outcome Measure Information:
Title
Limbal Redness of Grade 3 or Above
Description
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.
Time Frame
After 6-8 days of lens wear
Title
Bulbar Redness of Grade 3 or Above
Description
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.
Time Frame
After 6-8 days of lens wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Pismo Beach
State/Province
California
Country
United States
City
Warwick
State/Province
Rhode Island
Country
United States
City
Fincastle
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs