Multifocal High ADD Contact Lens Proof of Concept Trial

NCT02117544 | Completed Results

• 1 other identifier: C-13-057
• Study Type: interventional
• Target: 268
• Locations: 0 countries
• Sites: N/A

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

Keywords

Contact lens; Presbyopia; Multifocal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• HCVA Distance Monocular

  Day 1, 10 minutes after lens insertion, each product

• HCVA Intermediate Monocular

  Day 1, 10 minutes after lens insertion, each product

• Low Contrast Visual Acuity (LCVA) Distance Monocular

  Day 1, 10 minutes after lens insertion, each product

Study Arms (2)

New MF, then AOAMF

OTHER

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); Device: Lotrafilcon B multifocal contact lenses

AOAMF, then New MF

OTHER

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); Device: Lotrafilcon B multifocal contact lenses

Interventions

Lotrafilcon B multifocal contact lenses (new) DEVICE

AOAMF, then New MF; New MF, then AOAMF

Lotrafilcon B multifocal contact lenses DEVICE

Also known as: AIR OPTIX® AQUA Multifocal, AOAMF

AOAMF, then New MF; New MF, then AOAMF

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Clinical Project Lead, Vision Care, GCRA
• Organization: Alcon Research, Ltd

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. Clinical Manager, Vision Care, GCRA

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 26, 2015
• Results First Posted: August 17, 2015

Record last verified: 2015-08