Multifocal High ADD Contact Lens Proof of Concept Trial

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Visual Performance With a Multifocal High ADD Soft Contact Lens Design

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Lotrafilcon B multifocal contact lenses (new)
* Device: Lotrafilcon B multifocal contact lenses


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: New MF, then AOAMF<br>Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (in both eyes) for about 1 hour. | Device: Lotrafilcon B multifocal contact lenses (new)<br> <br> Device: Lotrafilcon B multifocal contact lenses<br> <br> * Other names: AOAMF;|
| Other: AOAMF, then New MF<br>Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally (in both eyes) for about 1 hour. | Device: Lotrafilcon B multifocal contact lenses (new)<br> <br> Device: Lotrafilcon B multifocal contact lenses<br> <br> * Other names: AOAMF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1, 10 minutes after lens insertion, each product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1, 10 minutes after lens insertion, each product | 
| 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. | Day 1, 10 minutes after lens insertion, each product | 
| 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. | Day 1, 10 minutes after lens insertion, each product | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lens, Presbyopia, Multifocal