Back to resultsPerformance Evaluation of a New Daily Disposable Silicone Hydrogel Lens (TUNGSTEN)
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
delefilcon A contact lens
filcon II 3 contact lenses
narafilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility 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.
Sites / Locations
- University of Waterloo Centre for Contact Lens Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
delefilcon A
filcon II 3
narafilcon A
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Mean Value of Comfort During the Day
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
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
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
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
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
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
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"
The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01371552
Brief Title
Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens
Acronym
TUNGSTEN
Official Title
Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens (TUNGSTEN)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to compare a new daily disposable, silicone hydrogel contact lens to marketed daily disposable, silicone hydrogel contact lenses.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
delefilcon A
Arm Type
Experimental
Arm Description
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.
Arm Title
filcon II 3
Arm Type
Active Comparator
Arm Description
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.
Arm Title
narafilcon A
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
delefilcon A contact lens
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
filcon II 3 contact lenses
Other Intervention Name(s)
Clariti 1-DAY
Intervention Description
Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.
Intervention Type
Device
Intervention Name(s)
narafilcon A contact lenses
Other Intervention Name(s)
1-DAY ACUVUE TruEye
Intervention Description
Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.
Primary Outcome Measure Information:
Title
Mean Value of Comfort During the Day
Description
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.
Time Frame
Part 1: Day 2 at 4 hours, 8 hours, and 12 hours
Title
Mean Overall Comfort Given at End of Wear
Description
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.
Time Frame
Part 1: Day 3
Title
Mean Overall Quality of Vision at End of Wear
Description
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.
Time Frame
Part 1: Day 3
Title
Mean Overall Ease of Handling at End of Wear
Description
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.
Time Frame
Part 1: Day 3
Title
Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear
Description
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.
Time Frame
Part 1: Day 2
Title
Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear
Description
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.
Time Frame
Part 1: Day 3
Title
Lens Wettability
Description
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.
Time Frame
Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours
Title
Percentage of Participants Responding "Yes"
Description
The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know.
Time Frame
Part 2: Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD FAAO
Organizational Affiliation
Centre for Contact Lens Research, School of Optometry, University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Waterloo Centre for Contact Lens Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens
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