Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens (TUNGSTEN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01371552
First received: June 9, 2011
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

The purpose of this study was to compare a new daily disposable, silicone hydrogel contact lens to marketed daily disposable, silicone hydrogel contact lenses.


Condition Intervention
Myopia
Device: delefilcon A contact lens
Device: filcon II 3 contact lenses
Device: narafilcon A contact lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens (TUNGSTEN)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Value of Comfort During the Day [ Time Frame: Part 1: Day 2 at 4 hours, 8 hours, and 12 hours ] [ Designated as safety issue: No ]
    The participant recorded a number from 0 to 100 in response to the question, "How would you rate the comfort of your lenses over the last hour?" in which 0 = very poor and 100 = excellent. Comfort was assessed at 4 hours, 8 hours, and 12 hours, and the responses were averaged.

  • Mean Overall Comfort Given at End of Wear [ Time Frame: Part 1: Day 3 ] [ Designated as safety issue: No ]
    The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall comfort of these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day.

  • Mean Overall Quality of Vision at End of Wear [ Time Frame: Part 1: Day 3 ] [ Designated as safety issue: No ]
    The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall quality of vision while wearing these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day.

  • Mean Overall Ease of Handling at End of Wear [ Time Frame: Part 1: Day 3 ] [ Designated as safety issue: No ]
    The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall ease of handling these lenses?" in which 0 = very difficult and 100 = very easy. The end of wear questionnaire was completed at time of lens removal for that day.

  • Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear [ Time Frame: Part 1: Day 2 ] [ Designated as safety issue: No ]
    The participant circled a number from 0 to 4 in response to the question, "Over the entire day while wearing these contact lenses, how often did your eyes feel dry?" in which 0 = never, 1 = rarely, 2 = sometimes, 3 = frequently, 4 = constantly. The end of wear questionnaire was completed at time of lens removal for that day.

  • Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear [ Time Frame: Part 1: Day 3 ] [ Designated as safety issue: No ]
    The participant circled a number from 1 to 5 in response to the question, "Overall, which lens do you prefer - the lens you wore today or your regular lenses?" in which 1 = strongly prefer my regular lenses, 2 = prefer my regular lenses, 3 = no preference, 4 = prefer test lens, 5 = strongly prefer test lens. The end of wear questionnaire was completed at time of lens removal for that day.

  • Lens Wettability [ Time Frame: Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours ] [ Designated as safety issue: No ]
    Lens wettability was assessed by the investigator during slit-lamp examination and graded on a 0-4 scale in 0.25 steps, where 0 = excellent and 4 = severely reduced.

  • Percentage of Participants Responding "Yes" [ Time Frame: Part 2: Day 7 ] [ Designated as safety issue: No ]
    The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know.


Enrollment: 119
Study Start Date: May 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: delefilcon A
Part 1: Delefilcon A contact lenses, followed by filcon II 3 contact lenses and narafilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality.
Device: delefilcon A contact lens
Investigational, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1 and one week in Part 2.
Device: filcon II 3 contact lenses
Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.
Other Name: Clariti 1-DAY
Device: narafilcon A contact lenses
Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.
Other Name: 1-DAY ACUVUE TruEye
Active Comparator: filcon II 3
Part 1: Filcon II 3 contact lenses, followed by narafilcon A contact lenses and delefilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality.
Device: delefilcon A contact lens
Investigational, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1 and one week in Part 2.
Device: filcon II 3 contact lenses
Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.
Other Name: Clariti 1-DAY
Device: narafilcon A contact lenses
Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.
Other Name: 1-DAY ACUVUE TruEye
Active Comparator: narafilcon A
Part 1: Narafilcon A contact lenses, followed by filcon II 3 contact lenses and delefilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality.
Device: delefilcon A contact lens
Investigational, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1 and one week in Part 2.
Device: filcon II 3 contact lenses
Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.
Other Name: Clariti 1-DAY
Device: narafilcon A contact lenses
Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.
Other Name: 1-DAY ACUVUE TruEye

Detailed Description:

Part 1 of the study involved bilateral wear of three different types of marketed contact lenses. Each type of lens was worn for three consecutive days of daily disposable wear. Participants had been previously identified as symptomatic lens wearers or asymptomatic lens wearers, based upon their responses to a screening questionnaire. Participants wore each lens type for as long as they were comfortable during the day, but lenses were removed before sleep. After completion of Part 1, participants began Part 2, which included dispensing of the investigational study lens for up to one week of bilateral wear, with a single follow-up visit at the end of that period.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 17 years of age; full legal capacity to volunteer.
  • Ocular examination within the last two years
  • Correctable to a visual acuity of 20/30 or better (in each eye) with habitual vision correction.
  • Currently wearing soft contact lenses.
  • Clear corneas; no active ocular disease.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Currently wearing 1-DAY ACUVUE TruEye or Sauflon Clariti 1-DAY contact lenses.
  • Monovision.
  • Any ocular disease.
  • Never worn contact lenses before.
  • Corneal refractive surgery.
  • Uses topical ocular medicine.
  • 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: NCT01371552

Locations
Canada, Ontario
University of Waterloo Centre for Contact Lens Research
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
CIBA VISION
Investigators
Principal Investigator: Lyndon Jones, PhD FAAO Centre for Contact Lens Research, School of Optometry, University of Waterloo
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01371552     History of Changes
Other Study ID Numbers: P-371-C-100 v2, P/319/08/C
Study First Received: June 9, 2011
Results First Received: October 2, 2012
Last Updated: October 2, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014