Back to resultsClinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population
Primary Purpose
Refractive Error
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Delefilcon A contact lenses
Narafilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Error
Eligibility Criteria
Inclusion Criteria:
- Must sign an informed consent form;
- Habitual current daily disposable soft contact lenses wearer;
- Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
- Lenses within the power range specified in the protocol;
- Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;
- Acceptable lens fit with both study contact lenses;
- Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Currently wearing DT1 or TE sphere lenses;
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;
- Eye injury or surgery within 12 weeks immediately prior to enrollment;
- History of herpetic keratitis, ocular surgery or irregular cornea;
- Prior refractive surgery;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Participation in any clinical trial within 30 days of the enrollment visit;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- Contact Alcon Japan, Ltd. for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
DT1, then TE
TE, then DT1
Arm Description
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
Outcomes
Primary Outcome Measures
Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear
Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02710292
Brief Title
Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population
Official Title
Clinical Evaluation of DAILIES TOTAL 1® in Japanese Population - Comparison of Lens Centration Between DAILIES TOTAL 1® and 1-DAY ACUVUE® TruEye®
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 25, 2016 (Actual)
Primary Completion Date
September 14, 2016 (Actual)
Study Completion Date
September 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DT1, then TE
Arm Type
Other
Arm Description
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
Arm Title
TE, then DT1
Arm Type
Other
Arm Description
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
Intervention Type
Device
Intervention Name(s)
Delefilcon A contact lenses
Other Intervention Name(s)
DAILIES TOTAL 1®, DT1
Intervention Type
Device
Intervention Name(s)
Narafilcon A contact lenses
Other Intervention Name(s)
1-DAY ACUVUE® TruEye®
Primary Outcome Measure Information:
Title
Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear
Description
Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.
Time Frame
Day 10, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must sign an informed consent form;
Habitual current daily disposable soft contact lenses wearer;
Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
Lenses within the power range specified in the protocol;
Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;
Acceptable lens fit with both study contact lenses;
Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Currently wearing DT1 or TE sphere lenses;
Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;
Eye injury or surgery within 12 weeks immediately prior to enrollment;
History of herpetic keratitis, ocular surgery or irregular cornea;
Prior refractive surgery;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Participation in any clinical trial within 30 days of the enrollment visit;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, Clinical Development
Organizational Affiliation
Alcon Japan, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Japan, Ltd. for Trial Locations
City
Tokyo
ZIP/Postal Code
107-0052
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population
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