Back to resultsVisual Assessment of DAILIES® AquaComfort Plus® for Astigmatism as Compared to 1-DAY ACUVUE® MOIST® for Astigmatism
Primary Purpose
Astigmatism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nelfilcon A toric contact lenses
Etafilcon A toric contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism focused on measuring DACP Toric, DAILIES® AquaComfort Plus®, Astigmatism, Toric
Eligibility Criteria
Inclusion Criteria:
- Must sign an Informed Consent document;
- Wear toric soft contact lenses within the protocol-specified range;
- Cylinder equal or higher than -0.75 diopters (D) in both eyes;
- Have an acceptable fit with both study contact lenses;
- Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible;
- Best corrected visual acuity (BCVA) of 20/30 Snellen;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear;
- Use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Require presbyopic correction;
- Any ocular condition observed during examination at the enrollment visit;
- History of herpetic keratitis, ocular surgery or irregular cornea;
- Pregnant or lactating;
- Participation in any clinical trial within 30 days of the enrollment visit;
- Currently wearing Focus® DAILIES® Toric or 1-DAY ACUVUE® MOIST® for Astigmatism;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
DACP T, Then 1DAM A
1DAM A, Then DACP T
Arm Description
Nelfilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
Etafilcon A toric contact lenses worn first, with nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
Outcomes
Primary Outcome Measures
High Contrast Time Controlled Visual Acuity (TCVA) at Day 10
TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.
Secondary Outcome Measures
Lens Oscillation at Blink at Day 10
Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02071771
Brief Title
Visual Assessment of DAILIES® AquaComfort Plus® for Astigmatism as Compared to 1-DAY ACUVUE® MOIST® for Astigmatism
Official Title
DAILIES® AquaComfort Plus® Toric - Comparative Assessment of Visual and Mechanical Performance
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate functional vision associated with rotational stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE® MOIST® for Astigmatism (1DAM A).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
Keywords
DACP Toric, DAILIES® AquaComfort Plus®, Astigmatism, Toric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DACP T, Then 1DAM A
Arm Type
Other
Arm Description
Nelfilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
Arm Title
1DAM A, Then DACP T
Arm Type
Other
Arm Description
Etafilcon A toric contact lenses worn first, with nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
Intervention Type
Device
Intervention Name(s)
Nelfilcon A toric contact lenses
Other Intervention Name(s)
DACP Toric, DAILIES® AQUACOMFORT PLUS® TORIC
Intervention Type
Device
Intervention Name(s)
Etafilcon A toric contact lenses
Other Intervention Name(s)
1-DAY ACUVUE® MOIST® for Astigmatism
Primary Outcome Measure Information:
Title
High Contrast Time Controlled Visual Acuity (TCVA) at Day 10
Description
TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.
Time Frame
Day 10, each product
Secondary Outcome Measure Information:
Title
Lens Oscillation at Blink at Day 10
Description
Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only.
Time Frame
Day 10, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must sign an Informed Consent document;
Wear toric soft contact lenses within the protocol-specified range;
Cylinder equal or higher than -0.75 diopters (D) in both eyes;
Have an acceptable fit with both study contact lenses;
Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible;
Best corrected visual acuity (BCVA) of 20/30 Snellen;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear;
Use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Require presbyopic correction;
Any ocular condition observed during examination at the enrollment visit;
History of herpetic keratitis, ocular surgery or irregular cornea;
Pregnant or lactating;
Participation in any clinical trial within 30 days of the enrollment visit;
Currently wearing Focus® DAILIES® Toric or 1-DAY ACUVUE® MOIST® for Astigmatism;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, EMEA
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Visual Assessment of DAILIES® AquaComfort Plus® for Astigmatism as Compared to 1-DAY ACUVUE® MOIST® for Astigmatism
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