- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02117544
Multifocal High ADD Contact Lens Proof of Concept Trial
August 14, 2015 updated by: Alcon Research
Evaluation of Visual Performance With a Multifocal High ADD Soft Contact Lens Design
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
268
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: New MF, then AOAMF
Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses.
Each product worn bilaterally (in both eyes) for about 1 hour.
|
Other Names:
|
Other: AOAMF, then New MF
Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new).
Each product worn bilaterally (in both eyes) for about 1 hour.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
High Contrast Visual Acuity (HCVA) Near Monocular
Time Frame: Day 1, 10 minutes after lens insertion, each product
|
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.
|
Day 1, 10 minutes after lens insertion, each product
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HCVA Distance Monocular
Time Frame: Day 1, 10 minutes after lens insertion, each product
|
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.
|
Day 1, 10 minutes after lens insertion, each product
|
HCVA Intermediate Monocular
Time Frame: Day 1, 10 minutes after lens insertion, each product
|
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.
|
Day 1, 10 minutes after lens insertion, each product
|
Low Contrast Visual Acuity (LCVA) Distance Monocular
Time Frame: Day 1, 10 minutes after lens insertion, each product
|
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.
|
Day 1, 10 minutes after lens insertion, each product
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sr. Clinical Manager, Vision Care, GCRA, Alcon Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
April 16, 2014
First Submitted That Met QC Criteria
April 16, 2014
First Posted (Estimate)
April 21, 2014
Study Record Updates
Last Update Posted (Estimate)
August 26, 2015
Last Update Submitted That Met QC Criteria
August 14, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-13-057
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Presbyopia
-
Johnson & Johnson Vision Care, Inc.CompletedPresbyopia CorrectionUnited Kingdom
-
Bausch & Lomb IncorporatedCompletedMyopia and Hyperopia and PresbyopiaUnited States
-
Technolas Perfect Vision GmbHUnknownHyperopic PresbyopiaIreland
-
Lee, Steven, M.D.CompletedMyopia, | Hyperopia, | Astigmatism, | Presbyopia, | Eye Strain,
-
Allotex, Inc.RecruitingPresbyopiaCzechia, Ireland, Turkey, United Kingdom
-
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.LENZ Therapeutics, IncRecruiting
-
Coopervision, Inc.Centre for Ocular Research & Education, CanadaRecruitingPresbyopiaUnited States, Canada
-
Optall VisionRecruiting
-
Allotex, Inc.TerminatedPresbyopiaBelgium, Ireland, United Kingdom
-
Coopervision, Inc.CORECompletedPresbyopiaUnited States, Canada
Clinical Trials on Lotrafilcon B multifocal contact lenses (new)
-
Alcon ResearchCompletedRefractive Error | Presbyopia | Hyperopia
-
Alcon ResearchCompletedRefractive Errors | PresbyopiaUnited States, Canada, United Kingdom
-
Alcon ResearchCompleted
-
Alcon ResearchEnrolling by invitationRefractive ErrorsUnited States
-
Alcon ResearchCompleted
-
CIBA VISIONCompleted
-
CIBA VISIONUniversity of WaterlooCompleted