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DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance

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ClinicalTrials.gov Identifier: NCT02235831
Recruitment Status : Completed
First Posted : September 10, 2014
Results First Posted : January 18, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.

Condition or disease Intervention/treatment Phase
Presbyopia Refractive Error Device: Nelfilcon A MF contact lenses (DACP MF) Device: Nelfilcon A single vision contact lenses (DACP) Not Applicable

Detailed Description:
In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 5±1 days before switching to the next assigned product.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: DAILIES® AquaComfort Plus® MF - Comparative Assessment of Visual Performance Using Objective Measurements
Study Start Date : September 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: DACP MF
DACP MF worn first, followed by DACP and DACP MF (Low Add) as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF will be worn bilaterally (in both eyes).
Device: Nelfilcon A MF contact lenses (DACP MF)
Multifocal contact lenses in Low, Medium, High Add

Device: Nelfilcon A single vision contact lenses (DACP)
Active Comparator: DACP
DACP worn first, followed by DACP MF and DACP MF (Low Add), as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP worn as monovision (distance correction in one eye and near correction in the other eye).
Device: Nelfilcon A MF contact lenses (DACP MF)
Multifocal contact lenses in Low, Medium, High Add

Device: Nelfilcon A single vision contact lenses (DACP)
Active Comparator: DACP MF (Low Add)
DACP MF (Low Add) worn first, followed by DACP and DACP MF, as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF (Low Add) worn bilaterally (in both eyes).
Device: Nelfilcon A MF contact lenses (DACP MF)
Multifocal contact lenses in Low, Medium, High Add

Device: Nelfilcon A single vision contact lenses (DACP)



Primary Outcome Measures :
  1. Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance [ Time Frame: Day 5, each product ]
    Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.



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Ages Eligible for Study:   41 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week
  • Spectacle add between +1.50 and +2.50 diopters (D) (inclusive)
  • Requiring lenses within the power range of both study contact lenses to be fitted
  • Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1
  • Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance
  • Acceptable fit with both study contact lenses
  • Willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours per day, every day if possible
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Current multifocal contact lens wearer
  • Current monovision wearer or failed attempt with monovision
  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
  • Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator
  • Eye injury or surgery within 12 weeks immediately prior to enrollment in this trial
  • Any moderate or severe ocular condition observed during the slitlamp examination at the enrollment visit
  • History of herpetic keratitis, ocular surgery or irregular cornea
  • Prior refractive surgery (e.g. LASIK, PRK, etc)
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens
  • Habitually uncorrected anisometropia >2.00D
  • Clinically significant anisocoria
  • Participation in any clinical trial within 30 days of the enrollment visit
  • Other protocol-defined exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235831


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Clinical Manager, EMEA Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02235831     History of Changes
Other Study ID Numbers: CLT330-P001
First Posted: September 10, 2014    Key Record Dates
Results First Posted: January 18, 2016
Last Update Posted: July 11, 2016
Last Verified: June 2016
Keywords provided by Alcon Research:
DACP MF
DAILIES AquaComfort Plus® Multifocal
presbyopia
visual performance
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases