Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens

NCT ID: NCT01797783

Last Updated: 2014-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-04-30

Brief Summary

The purpose of this study was to demonstrate substantial equivalence of the new DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus® DAILIES® Progressives (FDP) contact lens.

Conditions

Myopia; Ametropia; Presbyopia; Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DAILIES® AquaComfort Plus® Multifocal

Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis

Group Type: EXPERIMENTAL

Nelfilcon A multifocal contact lens with comfort additive

Intervention Type: DEVICE

Focus® DAILIES® Progressives

Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis

Group Type: ACTIVE_COMPARATOR

Nelfilcon A multifocal contact lens

Intervention Type: DEVICE

Interventions

Nelfilcon A multifocal contact lens with comfort additive

Intervention Type: DEVICE

Nelfilcon A multifocal contact lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Sign Informed Consent Document.
• Presbyopic and require a spectacle add of up to and including 3.00 diopters (D).
• Currently wear soft contact lenses.
• Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule.
• Manifest cylinder less than or equal to 1.00 D.
• Able to achieve best corrected visual acuity (BCVA) of 20/25 or better (Snellen) in each eye at distance (as determined by manifest refraction).
• Able to achieve distance visual acuity of 20/40 (Snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense.

Exclusion Criteria

• Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated.
• History of corneal or refractive surgery.
• Biomicroscopy findings greater than Grade 2 at baseline.
• A pathologically dry eye that precludes contact lens wear.
• Monocular (only one eye with functional vision).
• Wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis).
• 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 or within the previous 30 days.
• Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justin Webb, O.D.

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-12-054

Identifier Type: -

Identifier Source: org_study_id