Clinical trial NCT01371552: Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens
Official title: Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens (TUNGSTEN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-06-13
Enrollment: 119
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Value of Comfort During the Day
timeFrame: Part 1: Day 2 at 4 hours, 8 hours, and 12 hours
measure: Mean Overall Comfort Given at End of Wear
timeFrame: Part 1: Day 3
measure: Mean Overall Quality of Vision at End of Wear
timeFrame: Part 1: Day 3
measure: Mean Overall Ease of Handling at End of Wear
timeFrame: Part 1: Day 3
measure: Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear
timeFrame: Part 1: Day 2
measure: Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear
timeFrame: Part 1: Day 3
measure: Lens Wettability
timeFrame: Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours
measure: Percentage of Participants Responding "Yes"
timeFrame: Part 2: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo Centre for Contact Lens Research
state: Ontario
Study officials:
affiliation: Centre for Contact Lens Research, School of Optometry, University of Waterloo
name: Lyndon Jones, PhD FAAO
role: PRINCIPAL_INVESTIGATOR
References: