Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses

This study has been completed.
Sponsor:
Collaborator:
Aston University
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01548833
First received: March 6, 2012
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.


Condition Intervention
Myopia
Device: Delefilcon A contact lens
Device: Narafilcon A contact lens
Device: Filcon II 3 contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Cross-Over Evaluation of Silicone Hydrogel Daily Disposable Soft Contact Lenses

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT) [ Time Frame: Day 7, 16 hours after lens insertion ] [ Designated as safety issue: No ]
    The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.


Enrollment: 39
Study Start Date: March 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dailies Total 1
Delefilcon A, followed by narafilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.
Device: Delefilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Other Name: DAILIES® TOTAL1™
Device: Narafilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Other Name: 1-DAY ACUVUE® TRUEYE™
Device: Filcon II 3 contact lens
Silicone hydrogel contact lens for single use, daily disposable wear
Other Name: Clariti™ 1-day
Active Comparator: TruEye
Narafilcon A, followed by delefilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.
Device: Delefilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Other Name: DAILIES® TOTAL1™
Device: Narafilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Other Name: 1-DAY ACUVUE® TRUEYE™
Device: Filcon II 3 contact lens
Silicone hydrogel contact lens for single use, daily disposable wear
Other Name: Clariti™ 1-day
Active Comparator: Clariti
Filcon II 3, followed by narafilcon A and delefilcon A in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.
Device: Delefilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Other Name: DAILIES® TOTAL1™
Device: Narafilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Other Name: 1-DAY ACUVUE® TRUEYE™
Device: Filcon II 3 contact lens
Silicone hydrogel contact lens for single use, daily disposable wear
Other Name: Clariti™ 1-day

  Eligibility

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

Inclusion Criteria:

  • Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate.
  • Require vision correction in both eyes.
  • Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction.
  • Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.
  • Willing and able to wear study contact lenses 16 hours per day.
  • Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses.
  • Require monovision correction.
  • Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.
  • Ocular surgery/trauma within the last 6 months.
  • Topical or systemic antibiotic use within 7 days of enrollment.
  • Topical ocular or systemic corticosteroid use within 14 days of enrollment.
  • Pregnant and nursing women.
  • Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548833

Sponsors and Collaborators
Alcon Research
Aston University
Investigators
Study Director: Jami Kern, PhD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01548833     History of Changes
Other Study ID Numbers: A00924
Study First Received: March 6, 2012
Results First Received: April 22, 2013
Last Updated: June 6, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Alcon Research:
Myopia
Contact Lenses

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 23, 2014