Back to resultsComparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
galy A Plus
seno A
galy A
Sponsored by
About this trial
This is an interventional other trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Must be at least 18 years of age and no more than 55 years of age.
- Must sign written informed consent.
- Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters.
- Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes.
- Must have visual acuity best correctable to 20/25+3 or better for each eye.
- Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No evidence of lid abnormality or infection; No conjunctival abnormality or infection; No clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); No other active ocular disease.
- The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
Exclusion Criteria:
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Any previous eye surgery involving the anterior segment.
- Pre-existing ocular disease that would preclude contact lens fitting.
- Abnormal lacrimal secretions.
- Keratoconus or other corneal irregularity.
- Pregnancy, lactating or planning a pregnancy at the time of enrollment.
- Participation in any concurrent clinical trial.
- Subject's habitual contact lens type is toric or multifocal.
- Require any concurrent ocular medication.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Other
Other
Other
Other
Other
Other
Arm Label
galy A Plus/ galy A / seno A
galy A Plus / seno A / galy A
galy A / galy A Plus / seno A
galy A / seno A / galy A Plus
seno A / galy A / glay A Plus
seno A / galy A Plus / galy A
Arm Description
Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 3: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: galy A -subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Outcomes
Primary Outcome Measures
Lens Centration Acceptance
Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.
Primary Gaze Lens Movement
Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.
Fit Acceptability
Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated.
Secondary Outcome Measures
New Lens Power Fit Match to Control Lenses
The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated.
Full Information
NCT ID
NCT01244529
First Posted
November 17, 2010
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01244529
Brief Title
Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2010 (Actual)
Primary Completion Date
November 1, 2010 (Actual)
Study Completion Date
November 1, 2010 (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
The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
galy A Plus/ galy A / seno A
Arm Type
Other
Arm Description
Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Arm Title
galy A Plus / seno A / galy A
Arm Type
Other
Arm Description
Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 3: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Arm Title
galy A / galy A Plus / seno A
Arm Type
Other
Arm Description
Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Arm Title
galy A / seno A / galy A Plus
Arm Type
Other
Arm Description
Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Arm Title
seno A / galy A / glay A Plus
Arm Type
Other
Arm Description
Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Arm Title
seno A / galy A Plus / galy A
Arm Type
Other
Arm Description
Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: galy A -subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Intervention Type
Device
Intervention Name(s)
galy A Plus
Intervention Description
galyfilcon A Plus, BC: 8.3 or 8.7
Intervention Type
Device
Intervention Name(s)
seno A
Intervention Description
senofilcon A, BC:8.4 or 8.8
Intervention Type
Device
Intervention Name(s)
galy A
Intervention Description
galyfilcon A , BC: 8.3 or 8.7
Primary Outcome Measure Information:
Title
Lens Centration Acceptance
Description
Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.
Time Frame
after 15 minutes of contact lens wear
Title
Primary Gaze Lens Movement
Description
Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.
Time Frame
after 15 minutes of contact lens wear
Title
Fit Acceptability
Description
Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated.
Time Frame
after 15 minutes of contact lens wear
Secondary Outcome Measure Information:
Title
New Lens Power Fit Match to Control Lenses
Description
The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated.
Time Frame
after 15 minutes of contact lens wear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be at least 18 years of age and no more than 55 years of age.
Must sign written informed consent.
Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters.
Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes.
Must have visual acuity best correctable to 20/25+3 or better for each eye.
Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No evidence of lid abnormality or infection; No conjunctival abnormality or infection; No clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); No other active ocular disease.
The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
Exclusion Criteria:
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Any previous eye surgery involving the anterior segment.
Pre-existing ocular disease that would preclude contact lens fitting.
Abnormal lacrimal secretions.
Keratoconus or other corneal irregularity.
Pregnancy, lactating or planning a pregnancy at the time of enrollment.
Participation in any concurrent clinical trial.
Subject's habitual contact lens type is toric or multifocal.
Require any concurrent ocular medication.
Facility Information:
City
Farnham
State/Province
Surrey
ZIP/Postal Code
GU9 7EN
Country
United Kingdom
City
Birmingham
ZIP/Postal Code
B4 7ET
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers
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