Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens

NCT01371552 | Completed Results

• 2 other identifiers: P-371-C-100 v2P/319/08/C
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

delefilcon A

EXPERIMENTAL

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; Device: filcon II 3 contact lenses; Device: narafilcon A contact lenses

filcon II 3

ACTIVE COMPARATOR

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; Device: filcon II 3 contact lenses; Device: narafilcon A contact lenses

narafilcon A

ACTIVE COMPARATOR

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; Device: filcon II 3 contact lenses; Device: narafilcon A contact lenses

Interventions

delefilcon A contact lens DEVICE

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.

delefilcon A; filcon II 3; narafilcon A

filcon II 3 contact lenses DEVICE

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

Also known as: Clariti 1-DAY

delefilcon A; filcon II 3; narafilcon A

narafilcon A contact lenses DEVICE

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

Also known as: 1-DAY ACUVUE TruEye

delefilcon A; filcon II 3; narafilcon A

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CIBA VISION: lead

Study Sites (1)

University of Waterloo Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Joachim Nick, Dipl. Ing.
• Organization: Alcon Research, Ltd.

joachim.nick@cibavision.com

+49 6022 240 520

Study Officials

• Lyndon Jones, PhD FAAO

  Centre for Contact Lens Research, School of Optometry, University of Waterloo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 13, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 31, 2012
• Results First Posted: October 31, 2012

Record last verified: 2012-10

Locations

CA (1)