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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01917162
First Posted: August 6, 2013
Last Update Posted: November 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01917162     History of Changes
Other Study ID Numbers: C-13-033
First Submitted: August 4, 2013
First Posted: August 6, 2013
Last Update Posted: November 7, 2013
Last Verified: November 2013

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