Back to resultsClinical Assessment of DAILIES TOTAL1® (DT1) Multifocal
Primary Purpose
Refractive Error
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Delefilcon A multifocal contact lenses
Habitual multifocal contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Error focused on measuring myopia, presbyopia
Eligibility Criteria
Inclusion Criteria:
- Must sign an informed consent document;
- Current daily wearer of soft multifocal contact lenses for at least 6 months with symptoms of contact lens discomfort as defined by the prescreening Eligibility Questionnaire;
- Requires a near spectacle add of +0.50 to +2.50 diopters (D) (inclusive);
- Requires lenses within the power range of study lenses to be fitted;
- Best corrected VA (BCVA) of 20/30 (0.2 logarithmic minimum angle of resolution [logMAR]) or better in each eye at distance;
- Willing to wear study lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Any eye condition that contraindicates wearing contact lenses as determined by the Investigator;
- Any use of medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- Monocular (only one eye functional) or fit with only 1 lens;
- Fitted with monovision;
- Prior refractive surgery (e.g., laser vision correction, photorefractive keratectomy, etc.);
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Currently wearing DT1 MF contact lenses;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
DT1 MF, then Habitual
Habitual, then DT1 MF
Arm Description
Delefilcon A multifocal contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
Outcomes
Primary Outcome Measures
Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.
Secondary Outcome Measures
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology.
Full Information
NCT ID
NCT02871375
First Posted
August 15, 2016
Last Updated
May 31, 2018
Sponsor
Alcon, a Novartis Company
1. Study Identification
Unique Protocol Identification Number
NCT02871375
Brief Title
Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal
Official Title
DAILIES TOTAL1® Multifocal Clinical Assessment in Challenging Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 30, 2016 (Actual)
Primary Completion Date
November 14, 2016 (Actual)
Study Completion Date
November 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon, a Novartis Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate DAILIES TOTAL1® Multifocal (DTl MF) contact lenses in current multifocal contact lens wearers with symptoms of end of day discomfort compared to their habitual multifocal contact lens correction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
Keywords
myopia, presbyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DT1 MF, then Habitual
Arm Type
Other
Arm Description
Delefilcon A multifocal contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
Arm Title
Habitual, then DT1 MF
Arm Type
Other
Arm Description
Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
Intervention Type
Device
Intervention Name(s)
Delefilcon A multifocal contact lenses
Other Intervention Name(s)
DAILIES TOTAL1® multifocal
Intervention Description
Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)
Intervention Type
Device
Intervention Name(s)
Habitual multifocal contact lenses
Intervention Description
Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality
Primary Outcome Measure Information:
Title
Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)
Description
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.
Time Frame
Day 14, each product
Secondary Outcome Measure Information:
Title
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
Description
The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology.
Time Frame
Day 14, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must sign an informed consent document;
Current daily wearer of soft multifocal contact lenses for at least 6 months with symptoms of contact lens discomfort as defined by the prescreening Eligibility Questionnaire;
Requires a near spectacle add of +0.50 to +2.50 diopters (D) (inclusive);
Requires lenses within the power range of study lenses to be fitted;
Best corrected VA (BCVA) of 20/30 (0.2 logarithmic minimum angle of resolution [logMAR]) or better in each eye at distance;
Willing to wear study lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Any eye condition that contraindicates wearing contact lenses as determined by the Investigator;
Any use of medications for which contact lens wear could be contraindicated, as determined by the Investigator;
Monocular (only one eye functional) or fit with only 1 lens;
Fitted with monovision;
Prior refractive surgery (e.g., laser vision correction, photorefractive keratectomy, etc.);
History of herpetic keratitis, ocular surgery, or irregular cornea;
Currently wearing DT1 MF contact lenses;
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager, PLS
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal
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