Back to resultsMultifocal High ADD Contact Lens Proof of Concept Trial
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon B multifocal contact lenses (new)
Lotrafilcon B multifocal contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring Contact lens, Presbyopia, Multifocal
Eligibility Criteria
Inclusion Criteria:
- Must sign an Informed Consent document;
- Presbyopic and require at least 2.25 diopters (D) spectacle ADD power;
- Current or previous soft contact lens wearer;
- Not able to achieve monocular near visual acuity (VA) 0.2 logarithm of the Minimum Angle of Resolution (logMAR) [Early Treatment of Diabetic Retinopathy Study (ETDRS)] or better in each eye with AIR OPTIX® AQUA Multifocal (AOAMF) High ADD Contact Lenses;
- Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial;
- Manifest cylinder less than or equal to 1.00 D;
- Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at distance (as determined by manifest refraction);
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment, as determined by the investigator;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; or any use of topical ocular medications that would require instillation during contact lens wear;
- Any history of herpetic keratitis;
- History of corneal or refractive surgery, irregular cornea or unilateral pseudophakia;
- Biomicroscopy findings (except for corneal vascularization) that are moderate (Grade 3) or severe (Grade 4);
- Corneal vascularization that is mild (Grade 2) or higher;
- A pathologically dry eye that precludes contact lens wear;
- Monocular (only 1 eye with functional vision);
- Anisometropia ≥ 1.50 D (contact lens distance prescription);
- Clinically significant (> 1 millimeter) anisocoria;
- History of intolerance or hypersensitivity to any component of the investigational products;
- Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
- Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
- Any ocular or systemic medical condition that may, in the opinion of the Investigator, preclude safe administration of the study lenses or affect the results of this study;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
New MF, then AOAMF
AOAMF, then New MF
Arm Description
Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (in both eyes) for about 1 hour.
Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally (in both eyes) for about 1 hour.
Outcomes
Primary Outcome Measures
High Contrast Visual Acuity (HCVA) Near Monocular
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Secondary Outcome Measures
HCVA Distance Monocular
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
HCVA Intermediate Monocular
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Low Contrast Visual Acuity (LCVA) Distance Monocular
Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02117544
Brief Title
Multifocal High ADD Contact Lens Proof of Concept Trial
Official Title
Evaluation of Visual Performance With a Multifocal High ADD Soft Contact Lens Design
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (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 a new multifocal High ADD contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD Contact Lens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Contact lens, Presbyopia, Multifocal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
268 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New MF, then AOAMF
Arm Type
Other
Arm Description
Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (in both eyes) for about 1 hour.
Arm Title
AOAMF, then New MF
Arm Type
Other
Arm Description
Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally (in both eyes) for about 1 hour.
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B multifocal contact lenses (new)
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B multifocal contact lenses
Other Intervention Name(s)
AIR OPTIX® AQUA Multifocal, AOAMF
Primary Outcome Measure Information:
Title
High Contrast Visual Acuity (HCVA) Near Monocular
Description
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time Frame
Day 1, 10 minutes after lens insertion, each product
Secondary Outcome Measure Information:
Title
HCVA Distance Monocular
Description
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time Frame
Day 1, 10 minutes after lens insertion, each product
Title
HCVA Intermediate Monocular
Description
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time Frame
Day 1, 10 minutes after lens insertion, each product
Title
Low Contrast Visual Acuity (LCVA) Distance Monocular
Description
Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time Frame
Day 1, 10 minutes after lens insertion, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must sign an Informed Consent document;
Presbyopic and require at least 2.25 diopters (D) spectacle ADD power;
Current or previous soft contact lens wearer;
Not able to achieve monocular near visual acuity (VA) 0.2 logarithm of the Minimum Angle of Resolution (logMAR) [Early Treatment of Diabetic Retinopathy Study (ETDRS)] or better in each eye with AIR OPTIX® AQUA Multifocal (AOAMF) High ADD Contact Lenses;
Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial;
Manifest cylinder less than or equal to 1.00 D;
Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at distance (as determined by manifest refraction);
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment, as determined by the investigator;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; or any use of topical ocular medications that would require instillation during contact lens wear;
Any history of herpetic keratitis;
History of corneal or refractive surgery, irregular cornea or unilateral pseudophakia;
Biomicroscopy findings (except for corneal vascularization) that are moderate (Grade 3) or severe (Grade 4);
Corneal vascularization that is mild (Grade 2) or higher;
A pathologically dry eye that precludes contact lens wear;
Monocular (only 1 eye with functional vision);
Anisometropia ≥ 1.50 D (contact lens distance prescription);
Clinically significant (> 1 millimeter) anisocoria;
History of intolerance or hypersensitivity to any component of the investigational products;
Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
Any ocular or systemic medical condition that may, in the opinion of the Investigator, preclude safe administration of the study lenses or affect the results of this study;
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Manager, Vision Care, GCRA
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Multifocal High ADD Contact Lens Proof of Concept Trial
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