Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02403180
Recruitment Status : Completed
First Posted : March 31, 2015
Results First Posted : August 18, 2016
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D MF daily disposable contact lenses in an established presbyopic population.

Condition or disease Intervention/treatment Phase
Presbyopia Device: DACP MF Device: PROCLEAR 1D MF Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Assessment of Visual Performance Between DAILIES® AquaComfort Plus® (DACP) Multifocal (MF) and PROCLEAR 1 Day Multifocal (PROCLEAR 1D MF)
Study Start Date : May 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
DACP MF, then PROCLEAR 1D MF
DACP MF (nelfilcon A) multifocal contact lenses worn in Period 1, followed by PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
Device: DACP MF
Nelfilcon A multifocal contact lenses
Other Names:
  • DAILIES® AquaComfort Plus® Multifocal (DACP MF)
  • Nelfilcon A

Device: PROCLEAR 1D MF
Omafilcon A multifocal contact lenses
Other Names:
  • PROCLEAR® 1 DAY MULTIFOCAL (PROCLEAR 1D MF)
  • Omafilcon A

PROCLEAR 1D MF, then DACP MF
PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 1, followed by DACP MF (nelfilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
Device: DACP MF
Nelfilcon A multifocal contact lenses
Other Names:
  • DAILIES® AquaComfort Plus® Multifocal (DACP MF)
  • Nelfilcon A

Device: PROCLEAR 1D MF
Omafilcon A multifocal contact lenses
Other Names:
  • PROCLEAR® 1 DAY MULTIFOCAL (PROCLEAR 1D MF)
  • Omafilcon A




Primary Outcome Measures :
  1. Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear [ Time Frame: Day 5, each product ]
    Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.


Secondary Outcome Measures :
  1. Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear [ 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. Trial 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Must sign an informed consent;
  • Adapted soft contact lens wearer;
  • Vision correctable to 20/30 [(0.2 logMAR (logarithm of the minimum angle of resolution)] or better in each eye at distance;
  • Willing to wear lenses every day or for at least 5 days per week, 6 hours per day;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Currently wearing multifocal contact lenses;
  • Currently wearing monovision;
  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
  • Use of systemic or ocular medications which could contraindicate contact lens wear;
  • Eye injury or surgery within 12 weeks prior to enrollment;
  • Prior refractive surgery;
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens;
  • Other protocol-specified 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): NCT02403180


Sponsors and Collaborators
Alcon Research
Investigators
Layout table for investigator information
Study Director: Clinical Manager Alcon, Spain

Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02403180     History of Changes
Other Study ID Numbers: CLW681-P001
First Posted: March 31, 2015    Key Record Dates
Results First Posted: August 18, 2016
Last Update Posted: August 18, 2016
Last Verified: July 2016
Keywords provided by Alcon Research:
Visual Performance
Additional relevant MeSH terms:
Layout table for MeSH terms
Presbyopia
Refractive Errors
Eye Diseases