Back to resultsClinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye®
Primary Purpose
Refractive Error
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stenfilcon A contact lenses
Narafilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Error focused on measuring Contact lenses
Eligibility Criteria
Inclusion Criteria:
- Must sign informed consent form.
- Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months.
- Willing to wear lenses every day or at least 5 days per week 6 hours per day.
- Willing to discontinue artificial tears and rewetting drops usage on the days of study visits.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Monocular (only 1 eye with functional vision) or fit with only 1 lens.
- Pregnant or lactating.
- Current MyDay™ or 1DAY ACUVUE® TruEye® lens wearer.
- Any abnormal ocular condition as specified in the protocol.
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
MyDay, then 1DAVTE
1DAVTE, then MyDay
Arm Description
Stenfilcon A contact lenses, followed by narafilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.
Narafilcon A contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
Outcomes
Primary Outcome Measures
High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10
High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. 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
High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10
High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02388763
Brief Title
Clinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye®
Official Title
Clinical Evaluation of MyDay™ Daily Disposable Silicone Hydrogel Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (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 the functional vision of 2 daily disposable silicone hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced humidity environment.
Detailed Description
After randomization, participants attended a baseline visit to include a 3 hour exposure to reduced humidity environment. The participant's habitual lenses were worn for the baseline visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
Keywords
Contact lenses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MyDay, then 1DAVTE
Arm Type
Other
Arm Description
Stenfilcon A contact lenses, followed by narafilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.
Arm Title
1DAVTE, then MyDay
Arm Type
Other
Arm Description
Narafilcon A contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
Intervention Type
Device
Intervention Name(s)
Stenfilcon A contact lenses
Other Intervention Name(s)
MyDay™
Intervention Description
Contact lenses worn during Period 1 or 2, as randomized
Intervention Type
Device
Intervention Name(s)
Narafilcon A contact lenses
Other Intervention Name(s)
1-DAY ACUVUE® TruEye®
Intervention Description
Contact lenses worn during Period 1 or 2, as randomized
Primary Outcome Measure Information:
Title
High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10
Description
High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. 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
High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10
Description
High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.
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 informed consent form.
Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months.
Willing to wear lenses every day or at least 5 days per week 6 hours per day.
Willing to discontinue artificial tears and rewetting drops usage on the days of study visits.
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Monocular (only 1 eye with functional vision) or fit with only 1 lens.
Pregnant or lactating.
Current MyDay™ or 1DAY ACUVUE® TruEye® lens wearer.
Any abnormal ocular condition as specified in the protocol.
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Manager, EMEA
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye®
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