TUNGSTEN: Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01371552
• Collaborator: (none)
• Enrollment: 119
• Location: 1
• Arms: 3
• Duration (Months): 3
• Patients Per Site Per Month: 39.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: delefilcon A contact lens; Device: filcon II 3 contact lenses; Device: narafilcon A contact lenses	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 119 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens (TUNGSTEN)
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 1-DAY ACUVUE TruEye

Outcome Measures

Primary Outcome Measures

1. Mean Value of Comfort During the Day [Part 1: Day 2 at 4 hours, 8 hours, and 12 hours]

   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.

2. Mean Overall Comfort Given at End of Wear [Part 1: Day 3]

   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.

3. Mean Overall Quality of Vision at End of Wear [Part 1: Day 3]

   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.

4. Mean Overall Ease of Handling at End of Wear [Part 1: Day 3]

   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.

5. Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear [Part 1: Day 2]

   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.

6. Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear [Part 1: Day 3]

   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.

7. Lens Wettability [Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours]

   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.

8. Percentage of Participants Responding "Yes" [Part 2: Day 7]

   The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT01371552
• Other Study ID Numbers: P-371-C-100 v2; P/319/08/C
• First Posted: Jun 13, 2011
• Last Update Posted: Oct 31, 2012
• Last Verified: Oct 1, 2012

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 1 study center in Canada.
Pre-assignment Detail	10 people were enrolled but not dispensed into Part 1 due to failing inclusion/exclusion criteria.

Arm/Group Title	Delefilcon A / Filcon II 3 / Narafilcon A	Narafilcon A / Filcon II 3 / Delefilcon A	Filcon II 3 / Narafilcon A / Delefilcon A	Delefilcon A / Narafilcon A / Filcon II 3	Narafilcon A / Delefilcon A / Filcon II 3	Filcon II 3 / Delefilcon A / Narafilcon A
Arm/Group Description	Part 1: Delefilcon A, then Filcon II 3, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.	Part 1: Narafilcon A, then Filcon II 3, then Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.	Part 1: Filcon II 3, then Narafilcon A, the Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.	Part 1: Delefilcon A, then Narafilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.	Part 1: Narafilcon A, then Delefilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.	Part 1: Filcon II 3, then Delefilcon A, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
Period Title: Part 1, First 3 Days
STARTED	19	17	20	20	15	18
COMPLETED	19	17	19	20	15	18
NOT COMPLETED	0	0	1	0	0	0
Period Title: Part 1, First 3 Days
STARTED	19	17	18	20	15	18
COMPLETED	18	17	18	20	15	18
NOT COMPLETED	1	0	0	0	0	0
Period Title: Part 1, First 3 Days
STARTED	19	17	18	20	15	18
COMPLETED	19	17	18	20	14	17
NOT COMPLETED	0	0	0	0	1	1
Period Title: Part 1, First 3 Days
STARTED	18	17	18	20	15	18
COMPLETED	18	17	18	20	15	18
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	This reporting group includes all enrolled participants.
Overall Participants	119
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27 (9)
Sex: Female, Male (Count of Participants)
Female	89 74.8%
Male	30 25.2%
Region of Enrollment (participants) [Number]
Canada	119 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed 12 hours of lens wear on Day 2.

Arm/Group Title	Delefilcon A	Filcon II 3	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1	Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1	Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
Measure Participants	94	88	85
Mean (Standard Deviation) [Units on a scale]	89 (11)	85 (13)	86 (13)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed all three lens wear periods in Part 1.

Arm/Group Title	Delefilcon A	Filcon II 3	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1	Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1	Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
Measure Participants	104	104	104
Mean (Standard Deviation) [Units on a scale]	90 (10)	83 (16)	86 (15)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed all three lens wear periods in Part 1.

Arm/Group Title	Delefilcon A	Filcon II 3	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1	Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1	Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
Measure Participants	104	104	104
Mean (Standard Deviation) [Units on a scale]	91 (10)	87 (12)	88 (13)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed all three lens wear periods in Part 1.

Arm/Group Title	Delefilcon A	Filcon II 3	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1	Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1	Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
Measure Participants	104	104	104
Mean (Standard Deviation) [Units on a scale]	90 (13)	91 (12)	93 (10)

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed all three lens wear periods in Part 1.

Arm/Group Title	Delefilcon A	Filcon II 3	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1	Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1	Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
Measure Participants	104	104	104
Number [Percentage of participants]	63 52.9%	38 NaN	57 NaN

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed all three lens wear periods in Part 1.

Arm/Group Title	Delefilcon A	Filcon II 3	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1	Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1	Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
Measure Participants	104	104	104
Number [Percentage of participants]	62 52.1%	35 NaN	54 NaN

7. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed all three lens wear periods in Part 1.

Arm/Group Title	Delefilcon A	Filcon II 3	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1	Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1	Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
Measure Participants	104	104	104
Day 1 at Dispense	0.25 (0.39)	0.49 (0.50)	0.46 (0.46)
Day 1 at 8 hours	0.46 (0.50)	0.77 (0.55)	0.89 (0.69)
Day 3 at 8 hours	0.51 (0.47)	0.76 (0.66)	0.91 (0.72)

8. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed Part 2.

Arm/Group Title	Delefilcon A - All Wearers
Arm/Group Description	Delefilcon A contact lenses worn in a daily disposable mode for 7 days in Part 2, all wearers
Measure Participants	106
These lenses provide excellent comfort	85 71.4%
These lenses provide excellent quality of vision	87 73.1%
These lenses are very easy to handle	83 69.7%
These lenses are very easy to insert on my eye	88 73.9%
Lenses provide excellent comfort during the day	89 74.8%
Lenses provide excellent comfort at the end of day	64 53.8%
So comfortable I almost forget I am wearing lenses	67 56.3%
Deliver comfort/vision long days/demanding schedul	72 60.5%
Total package-great vision, comfort, convenience	73 61.3%
My life is demanding. Lenses meet those demands	64 53.8%
I need high performance-these lenses deliver	70 58.8%

Adverse Events

Time Frame	Adverse events were collected for the duration of the study.
Adverse Event Reporting Description	The safety reporting group includes all enrolled and exposed participants.
Arm/Group Title	Delefilcon A		Filcon II 3		Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1		Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1		Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
All Cause Mortality
	Delefilcon A		Filcon II 3		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Delefilcon A		Filcon II 3		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/117 (0%)		0/117 (0%)		0/117 (0%)
Other (Not Including Serious) Adverse Events
	Delefilcon A		Filcon II 3		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/117 (0%)		12/117 (10.3%)		1/117 (0.9%)
Eye disorders
Redness	0/115 (0%)		12/117 (10.3%)		1/115 (0.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.