Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myopia

Intervention / Treatment
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* Device: delefilcon A contact lens
* Device: filcon II 3 contact lenses
* Device: narafilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: delefilcon A<br>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<br>* 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.<br>Device: filcon II 3 contact lenses<br>* Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.<br>* Other names: Clariti 1-DAY;Device: narafilcon A contact lenses<br>* Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.<br>* Other names: 1-DAY ACUVUE TruEye;|
| Active Comparator: filcon II 3<br>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<br>* 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.<br>Device: filcon II 3 contact lenses<br>* Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.<br>* Other names: Clariti 1-DAY;Device: narafilcon A contact lenses<br>* Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.<br>* Other names: 1-DAY ACUVUE TruEye;|
| Active Comparator: narafilcon A<br>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<br>* 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.<br>Device: filcon II 3 contact lenses<br>* Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.<br>* Other names: Clariti 1-DAY;Device: narafilcon A contact lenses<br>* Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.<br>* Other names: 1-DAY ACUVUE TruEye;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Part 1: Day 2 at 4 hours, 8 hours, and 12 hours | 
| 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. | Part 1: Day 3 | 
| 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. | Part 1: Day 3 | 
| 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. | Part 1: Day 3 | 
| 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. | Part 1: Day 2 | 
| 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. | Part 1: Day 3 | 
| 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. | Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours | 
| 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. | Part 2: Day 7 |