Clinical trial NCT02117544: 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
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Contact lens
Presbyopia
Multifocal
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 268
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: High Contrast Visual Acuity (HCVA) Near Monocular
timeFrame: Day 1, 10 minutes after lens insertion, each product
Secondary outcomes:
measure: HCVA Distance Monocular
timeFrame: Day 1, 10 minutes after lens insertion, each product
measure: HCVA Intermediate Monocular
timeFrame: Day 1, 10 minutes after lens insertion, each product
measure: Low Contrast Visual Acuity (LCVA) Distance Monocular
timeFrame: Day 1, 10 minutes after lens insertion, each product
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sr. Clinical Manager, Vision Care, GCRA
role: STUDY_DIRECTOR
References: