Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens

Myopia Clinical Trial

— TUNGSTEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371552
• Other study ID #: P-371-C-100 v2
• Secondary ID: P/319/08/C
• Status: Completed
• Phase: N/A
• First received: June 9, 2011
• Last updated: October 2, 2012
• Start date: May 2011
• Est. completion date: August 2011

Study information

• Verified date: October 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

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.
• 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.
• narafilcon A contact lenses
Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.

Locations

Country	Name	City	State
Canada	University of Waterloo Centre for Contact Lens Research	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No