Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses (Study 2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01917162
First received: August 4, 2013
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.


Condition Intervention
Refractive Error
Device: Nelfilcon A contact lens
Device: UltraFilcon B contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Initial comfort [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Initial Comfort (within 10-15 minutes of lens insertion) will be assessed bilaterally by the participant at time of dispense. Initial Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).


Secondary Outcome Measures:
  • End of Day Comfort [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    End of Day Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. End of Day Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).

  • Overall Comfort [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Overall Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).

  • Overall Handling at Time of Removal [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Overall Handling at Time of Removal will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Handling at Time of Removal will be graded on a 1-10 scale (10=excellent, very easy; 1=unmanageable).


Enrollment: 86
Study Start Date: September 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nelfilcon A/UltraFilcon B
Nelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.
Device: Nelfilcon A contact lens
Soft contact lens CE-marked for daily disposable wear.
Other Name: DAILIES® AquaComfort Plus®
Device: UltraFilcon B contact lens
Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.
Other Name: Procornea BYO Air Daily
UltraFilcon B/Nelfilcon A
UltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.
Device: Nelfilcon A contact lens
Soft contact lens CE-marked for daily disposable wear.
Other Name: DAILIES® AquaComfort Plus®
Device: UltraFilcon B contact lens
Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.
Other Name: Procornea BYO Air Daily

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adapted soft contact lens wearer;
  • Spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive);
  • Spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other;
  • Correctable to 6/9 (20/30) in both eyes;
  • Read, understand, and sign the informed consent;
  • Willing to comply with the wear schedule;
  • Willing to comply with the study visit schedule;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any active corneal infection, injury or inflammation;
  • Systemic or ocular allergies which might interfere with contact lens wear;
  • Systemic or ocular disease which might interfere with contact lens wear;
  • Strabismus or amblyopia;
  • Corneal refractive surgery and any anterior segment surgery;
  • Use of systemic/topical medication contraindicating contact lens wear;
  • Use of gas permeable contact lenses within 1 month preceding the study;
  • Participation in any concurrent clinical trial or in the last 30 days;
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917162

Locations
United Kingdom
Visioncare Research Ltd
Farnham, Surrey, United Kingdom, GU9 7EN
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Joachim Nick, Dipl. Ing. Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01917162     History of Changes
Other Study ID Numbers: C-13-033
Study First Received: August 4, 2013
Last Updated: November 6, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Alcon Research:
contact lenses
daily disposable contact lenses
silicone hydrogel
contact lens comfort
near-sighted

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014