Back to resultsTear Film Evaluation of Dailies® AquaComfort Plus® Multifocal and Toric
Primary Purpose
Refractive Error
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nelfilcon A multifocal contact lenses
Nelfilcon A toric contact lenses
Nelfilcon A sphere contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Error focused on measuring Dailies AquaComfort Plus® Multifocal (DACP MF), Dailies AquaComfort Plus® Toric (DACP Toric), tear film stability, Non-Invasive Keratograph Break-Up Time (NIK-BUT)
Eligibility Criteria
Inclusion Criteria:
- Must sign an informed consent document;
Adapted, current soft contact lens wearer with either:
- A spectacle add between +0.50 and +2.50 (inclusive) [Presbyopes group]
- A spherical correction of an astigmatism up to 20% of the amount of the sphere [Astigmats group];
- Contact lens prescription in the power range specified in the protocol;
- Vision correctable to 0.2 logMAR (logarithmic minimal angle for resolution) or better in each eye at distance with pre-study lenses or manifest refraction at Visit 1;
- Willing to wear study lenses up to 12 hours and attend all study visits;
- Can be successfully fitted with study lenses;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Any ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
- Use of artificial tears and rewetting drops during the study;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Any abnormal ocular condition observed during the Visit 1 slit-lamp examination;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Pregnant or lactating;
- Unstable tear film with a NIK-BUT value below 8 seconds in either eye without lenses;
- Participation in any clinical study within 30 days of Visit 1;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Arm1: Presbyopes
Arm2: Astigmats
Arm Description
Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
Outcomes
Primary Outcome Measures
Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear
A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.
Secondary Outcome Measures
Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear
A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02289742
Brief Title
Tear Film Evaluation of Dailies® AquaComfort Plus® Multifocal and Toric
Official Title
Characterization of Pre-Lens Tear Film Stability of Daily Disposable Multifocal and Toric Contact Lenses Using Ring Mire Projection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 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 pre lens tear film characteristics of DAILIES® Aqua Comfort Plus® Multifocal (DACP MF) and Toric (DACP Toric) compared to DAILIES® Aqua Comfort Plus® Sphere (DACP) daily disposable contact lenses over 12 hours of lens wear.
Detailed Description
Two population groups (presbyopes and astigmats) will be enrolled in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
Keywords
Dailies AquaComfort Plus® Multifocal (DACP MF), Dailies AquaComfort Plus® Toric (DACP Toric), tear film stability, Non-Invasive Keratograph Break-Up Time (NIK-BUT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm1: Presbyopes
Arm Type
Other
Arm Description
Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
Arm Title
Arm2: Astigmats
Arm Type
Other
Arm Description
Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
Intervention Type
Device
Intervention Name(s)
Nelfilcon A multifocal contact lenses
Other Intervention Name(s)
DAILIES® AquaComfort Plus® Multifocal, DACP MF
Intervention Type
Device
Intervention Name(s)
Nelfilcon A toric contact lenses
Other Intervention Name(s)
DAILIES® AquaComfort Plus® Toric, DACP Toric
Intervention Type
Device
Intervention Name(s)
Nelfilcon A sphere contact lenses
Other Intervention Name(s)
DAILIES® AquaComfort Plus®, DACP
Primary Outcome Measure Information:
Title
Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear
Description
A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.
Time Frame
Hour 12, each product
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear
Description
A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.
Time Frame
Hour 8, 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;
Adapted, current soft contact lens wearer with either:
A spectacle add between +0.50 and +2.50 (inclusive) [Presbyopes group]
A spherical correction of an astigmatism up to 20% of the amount of the sphere [Astigmats group];
Contact lens prescription in the power range specified in the protocol;
Vision correctable to 0.2 logMAR (logarithmic minimal angle for resolution) or better in each eye at distance with pre-study lenses or manifest refraction at Visit 1;
Willing to wear study lenses up to 12 hours and attend all study visits;
Can be successfully fitted with study lenses;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Any ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
Use of artificial tears and rewetting drops during the study;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Any abnormal ocular condition observed during the Visit 1 slit-lamp examination;
History of herpetic keratitis, ocular surgery, or irregular cornea;
Pregnant or lactating;
Unstable tear film with a NIK-BUT value below 8 seconds in either eye without lenses;
Participation in any clinical study within 30 days of Visit 1;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Manager, Global Med Affairs, Operations
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Tear Film Evaluation of Dailies® AquaComfort Plus® Multifocal and Toric
We'll reach out to this number within 24 hrs