Back to resultsA Comparison of Two Contact Lenses
Primary Purpose
Refractive Error, Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
senofilcon A
balafilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Error
Eligibility Criteria
Inclusion Criteria:
- They are of legal age (18 years) and capacity to volunteer.
- They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
- They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
- They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
- They have successfully worn contact lenses within six months of starting the study.
Exclusion Criteria:
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
- They are pregnant or lactating.
- They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
- They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
- They have diabetes.
- They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Sites / Locations
- Indiana University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
senofilcon A/balafilcon A
balafilcon A/senofilcon A
Arm Description
senofilcon A silicone hydrogel contact lens worn during first 4-week period, balafilcon A silicone hydrogel contact lens worn during the second 4-week period. Senofilcon A lenses worn daily on a 2-week replacement schedule; balafilcon A lenses worn daily on a 4-week replacement schedule. Lens replacement conducted in-office in a masked process.
balafilcon A silicone hydrogel contact lens worn worn during first 4-week period, senofilcon A silicone hydrogel contact lens worn during the second 4-week period. Senofilcon A lenses worn daily on a 2-week replacement schedule; balafilcon A lenses worn daily on a 4-week replacement schedule. Lens replacement conducted in-office in a masked process.
Outcomes
Primary Outcome Measures
Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A).
Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.
Secondary Outcome Measures
Full Information
NCT ID
NCT00700752
First Posted
June 17, 2008
Last Updated
May 5, 2015
Sponsor
Johnson & Johnson Vision Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00700752
Brief Title
A Comparison of Two Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
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
This study seeks to evaluate the clinical and subjective performance of two established soft contact lenses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error, Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
senofilcon A/balafilcon A
Arm Type
Active Comparator
Arm Description
senofilcon A silicone hydrogel contact lens worn during first 4-week period, balafilcon A silicone hydrogel contact lens worn during the second 4-week period. Senofilcon A lenses worn daily on a 2-week replacement schedule; balafilcon A lenses worn daily on a 4-week replacement schedule. Lens replacement conducted in-office in a masked process.
Arm Title
balafilcon A/senofilcon A
Arm Type
Active Comparator
Arm Description
balafilcon A silicone hydrogel contact lens worn worn during first 4-week period, senofilcon A silicone hydrogel contact lens worn during the second 4-week period. Senofilcon A lenses worn daily on a 2-week replacement schedule; balafilcon A lenses worn daily on a 4-week replacement schedule. Lens replacement conducted in-office in a masked process.
Intervention Type
Device
Intervention Name(s)
senofilcon A
Intervention Description
silicone hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
balafilcon A
Intervention Description
silicone hydrogel contact lens
Primary Outcome Measure Information:
Title
Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A).
Description
Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.
Time Frame
after 4 weeks of lens wear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
They are of legal age (18 years) and capacity to volunteer.
They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
They have successfully worn contact lenses within six months of starting the study.
Exclusion Criteria:
They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They are aphakic.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
They are pregnant or lactating.
They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
They have diabetes.
They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Facility Information:
Facility Name
Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Two Contact Lenses
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