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Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses

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ClinicalTrials.gov Identifier: NCT01898260
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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

Condition or disease Intervention/treatment Phase
Myopia Refractive Error Device: Ultrafilcon B contact lens Device: Stenfilcon A contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses
Study Start Date : August 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
BYO Daily, then MyDay
Ultrafilcon B contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 1 week in a daily wear, daily disposable modality.
Device: Ultrafilcon B contact lens
Silicone hydrogel contact lens CE-marked for daily disposable wear. Private-label versions may be used.
Other Name: Procornea BYO™ Air Daily
Device: Stenfilcon A contact lens
Silicone hydrogel contact lens CE-marked for daily disposable wear. Private-label versions may be used.
Other Name: MyDay™ Daily Disposable
MyDay, then BYO Daily
Stenfilcon A contact lenses, followed by ultrafilcon B contact lenses. Each product worn bilaterally for 1 week in a daily wear, daily disposable modality.
Device: Ultrafilcon B contact lens
Silicone hydrogel contact lens CE-marked for daily disposable wear. Private-label versions may be used.
Other Name: Procornea BYO™ Air Daily
Device: Stenfilcon A contact lens
Silicone hydrogel contact lens CE-marked for daily disposable wear. Private-label versions may be used.
Other Name: MyDay™ Daily Disposable



Primary Outcome Measures :
  1. Initial Comfort [ Time Frame: Baseline ]
    Initial Comfort 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 :
  1. 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).

  2. 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).

  3. 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).



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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, understood and signed 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.

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): NCT01898260


Locations
United Kingdom
Alcon Investigative Site
Surrey, United Kingdom
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Joachim Nick, Dipl. Ing. Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01898260     History of Changes
Other Study ID Numbers: C-13-032
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: October 2014

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