Back to resultsDAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DACP MF
PROCLEAR 1D MF
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring Visual Performance
Eligibility Criteria
Inclusion Criteria:
- Must sign an informed consent;
- Adapted soft contact lens wearer;
- Vision correctable to 20/30 [(0.2 logMAR (logarithm of the minimum angle of resolution)] or better in each eye at distance;
- Willing to wear lenses every day or for at least 5 days per week, 6 hours per day;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Currently wearing multifocal contact lenses;
- Currently wearing monovision;
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Use of systemic or ocular medications which could contraindicate contact lens wear;
- Eye injury or surgery within 12 weeks prior to enrollment;
- Prior refractive surgery;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
DACP MF, then PROCLEAR 1D MF
PROCLEAR 1D MF, then DACP MF
Arm Description
DACP MF (nelfilcon A) multifocal contact lenses worn in Period 1, followed by PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 1, followed by DACP MF (nelfilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
Outcomes
Primary Outcome Measures
Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear
Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.
Secondary Outcome Measures
Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear
Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Trial Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02403180
Brief Title
DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
Official Title
Comparative Assessment of Visual Performance Between DAILIES® AquaComfort Plus® (DACP) Multifocal (MF) and PROCLEAR 1 Day Multifocal (PROCLEAR 1D MF)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 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 visual performance of DACP MF and PROCLEAR 1D MF daily disposable contact lenses in an established presbyopic population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Visual Performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DACP MF, then PROCLEAR 1D MF
Arm Type
Other
Arm Description
DACP MF (nelfilcon A) multifocal contact lenses worn in Period 1, followed by PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
Arm Title
PROCLEAR 1D MF, then DACP MF
Arm Type
Other
Arm Description
PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 1, followed by DACP MF (nelfilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
Intervention Type
Device
Intervention Name(s)
DACP MF
Other Intervention Name(s)
DAILIES® AquaComfort Plus® Multifocal (DACP MF), Nelfilcon A
Intervention Description
Nelfilcon A multifocal contact lenses
Intervention Type
Device
Intervention Name(s)
PROCLEAR 1D MF
Other Intervention Name(s)
PROCLEAR® 1 DAY MULTIFOCAL (PROCLEAR 1D MF), Omafilcon A
Intervention Description
Omafilcon A multifocal contact lenses
Primary Outcome Measure Information:
Title
Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear
Description
Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.
Time Frame
Day 5, each product
Secondary Outcome Measure Information:
Title
Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear
Description
Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Trial Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus.
Time Frame
Day 5, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must sign an informed consent;
Adapted soft contact lens wearer;
Vision correctable to 20/30 [(0.2 logMAR (logarithm of the minimum angle of resolution)] or better in each eye at distance;
Willing to wear lenses every day or for at least 5 days per week, 6 hours per day;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Currently wearing multifocal contact lenses;
Currently wearing monovision;
Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
Use of systemic or ocular medications which could contraindicate contact lens wear;
Eye injury or surgery within 12 weeks prior to enrollment;
Prior refractive surgery;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager
Organizational Affiliation
Alcon, Spain
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
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