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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01797783
First received: February 21, 2013
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to compare the performance of the new DAILIES® AquaComfort Plus® Multifocal contact lens to the commercially available Focus® DAILIES® Progressives 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Subjective Overall Vision [ Time Frame: Up to Day 30 ] [ Designated as safety issue: No ]
    Subject will be instructed, "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." Subject will record response on a continuous scale from 1-10 (1 is poor and 10 is excellent).


Secondary Outcome Measures:
  • Binocular Snellen Visual Acuity (VA) at Distance with Study Lenses [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    As tested while reading charts at 20-foot equivalent distance with both eyes together in normal lighting. Snellen acuity is recorded in feet.

  • Binocular Snellen Visual Acuity (VA) at Near (40 cm) with Study Lenses [ Time Frame: Up to Day 30 ] [ Designated as safety issue: No ]
    As tested while reading a near point Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at 40 centimeters, also referred to as logMAR, or logarithmic Minimum Angle of Resolution, VA testing card, with both eyes together in normal lighting.


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
Multifocal soft contact lens with comfort additive for daily wear, daily disposable use
Other Name: DAILIES AquaComfort Plus Multifocal
Active Comparator: Focus DAILIES Progressive
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
Device: Nelfilcon A multifocal contact lens
Multifocal soft contact lens for daily wear, daily disposable use
Other Name: Focus DAILIES Progressives

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sign Informed Consent Document.
  • Presbyopic and requires a spectacle add of up to and including 3.00 diopter (D).
  • Currently wears soft contact lenses.
  • Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and to 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).
  • Wears 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01797783

Locations
United States, Texas
Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Justin Webb, O.D. Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01797783     History of Changes
Other Study ID Numbers: C-12-054
Study First Received: February 21, 2013
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

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 April 22, 2014