Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens - Full Text View

Purpose

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.

Condition	Intervention
Myopia Ametropia Presbyopia Refractive Error	Device: Nelfilcon A multifocal contact lens with comfort additive Device: Nelfilcon A multifocal contact lens


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment
Official Title:	Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Subjective Overall Vision [ Time Frame: Up to Day 30 ]
The participant was instructed to, "Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision." The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent).

Secondary Outcome Measures:

Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses [ Time Frame: Up to Day 30 ]
Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity.
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses [ Time Frame: Up to Day 30 ]
Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity.


Enrollment:	83
Study Start Date:	February 2013
Study Completion Date:	April 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: DAILIES® AquaComfort Plus® Multifocal Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis	Device: Nelfilcon A multifocal contact lens with comfort additive
Active Comparator: Focus® DAILIES® Progressives Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis	Device: Nelfilcon A multifocal contact lens

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.
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.
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.
Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797783

Sponsors and Collaborators

Alcon Research

Investigators


Study Director:	Justin Webb, O.D.	Alcon Research

More Information


Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT01797783 History of Changes
Other Study ID Numbers:	C-12-054
Study First Received:	February 21, 2013
Results First Received:	April 25, 2014
Last Updated:	April 25, 2014

Keywords provided by Alcon Research:


Myopia Presbyopia Refractive error Contact lenses Multifocal

Additional relevant MeSH terms:


Myopia Presbyopia Refractive Errors Eye Diseases

ClinicalTrials.gov processed this record on August 16, 2017