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Visual Assessment of DAILIES® AquaComfort Plus® for Astigmatism as Compared to 1-DAY ACUVUE® MOIST® for Astigmatism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT02071771
First received: February 24, 2014
Last updated: October 13, 2015
Last verified: October 2015
  Purpose
The purpose of this study is to evaluate functional vision associated with rotational stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE® MOIST® for Astigmatism (1DAM A).

Condition Intervention
Astigmatism
Device: Nelfilcon A toric contact lenses
Device: Etafilcon A toric contact lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: DAILIES® AquaComfort Plus® Toric - Comparative Assessment of Visual and Mechanical Performance

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • High Contrast Time Controlled Visual Acuity (TCVA) at Day 10 [ Time Frame: Day 10, each product ] [ Designated as safety issue: No ]
    TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.


Secondary Outcome Measures:
  • Lens Oscillation at Blink at Day 10 [ Time Frame: Day 10, each product ] [ Designated as safety issue: No ]
    Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only.


Enrollment: 80
Study Start Date: April 2014
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
DACP T, Then 1DAM A
Nelfilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
Device: Nelfilcon A toric contact lenses
Other Names:
  • DACP Toric
  • DAILIES® AQUACOMFORT PLUS® TORIC
Device: Etafilcon A toric contact lenses
Other Name: 1-DAY ACUVUE® MOIST® for Astigmatism
1DAM A, Then DACP T
Etafilcon A toric contact lenses worn first, with nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
Device: Nelfilcon A toric contact lenses
Other Names:
  • DACP Toric
  • DAILIES® AQUACOMFORT PLUS® TORIC
Device: Etafilcon A toric contact lenses
Other Name: 1-DAY ACUVUE® MOIST® for Astigmatism

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must sign an Informed Consent document;
  • Wear toric soft contact lenses within the protocol-specified range;
  • Cylinder equal or higher than -0.75 diopters (D) in both eyes;
  • Have an acceptable fit with both study contact lenses;
  • Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible;
  • Best corrected visual acuity (BCVA) of 20/30 Snellen;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear;
  • Use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator;
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens;
  • Require presbyopic correction;
  • Any ocular condition observed during examination at the enrollment visit;
  • History of herpetic keratitis, ocular surgery or irregular cornea;
  • Pregnant or lactating;
  • Participation in any clinical trial within 30 days of the enrollment visit;
  • Currently wearing Focus® DAILIES® Toric or 1-DAY ACUVUE® MOIST® for Astigmatism;
  • Other protocol-specified 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: NCT02071771

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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02071771     History of Changes
Other Study ID Numbers: M-14-007 
Study First Received: February 24, 2014
Results First Received: October 13, 2015
Last Updated: October 13, 2015
Health Authority: United States: Institutional Review Board
United Kingdom: Research Ethics Committee

Keywords provided by Alcon Research:
DACP Toric
DAILIES® AquaComfort Plus®
Astigmatism
Toric

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on September 23, 2016