Multifocal High ADD Contact Lens Proof of Concept Trial

NCT ID: NCT02117544

Last Updated: 2015-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-07-31

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.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

Lotrafilcon B multifocal contact lenses (new)

Intervention Type: DEVICE

Lotrafilcon B multifocal contact lenses

Intervention Type: DEVICE

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.

Group Type: OTHER

Lotrafilcon B multifocal contact lenses (new)

Intervention Type: DEVICE

Lotrafilcon B multifocal contact lenses

Intervention Type: DEVICE

Interventions

Lotrafilcon B multifocal contact lenses (new)

Intervention Type: DEVICE

Lotrafilcon B multifocal contact lenses

Intervention Type: DEVICE

Other Intervention Names

AIR OPTIX® AQUA Multifocal; AOAMF

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);

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;

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sr. Clinical Manager, Vision Care, GCRA

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-13-057

Identifier Type: -

Identifier Source: org_study_id