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
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: 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 July 22, 2014