Clinical Evaluation of an Investigational Soft Contact Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01254747
First received: December 3, 2010
Last updated: June 26, 2012
Last verified: April 2012
  Purpose

The purpose of this 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.


Condition Intervention
Myopia
Device: Delefilcon A contact lens
Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)
Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus)
Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Overall Comfort [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

  • Vision Quality During the Day [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.

  • Overall Handling [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.

  • Dryness Throughout the Day [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

  • Average Daily Wear Time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.


Secondary Outcome Measures:
  • Lens Fit [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.

  • Corrected Visual Acuity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.

  • Overall Satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.


Enrollment: 130
Study Start Date: November 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Delefilcon A
Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Device: Delefilcon A contact lens
Investigational silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Other Name: DAILIES TOTAL1®
Active Comparator: Lotrafilcon B
Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)
Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Other Names:
  • O2 OPTIX®
  • AIR OPTIX®
Active Comparator: Nelfilcon A
Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus)
Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use
Other Name: DAILIES® AquaComfort Plus®
Active Comparator: Narafilcon A
Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)
Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Other Name: 1-DAY ACUVUE® TRUEYE™

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Germany: Be of legal age.
  • USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent.
  • Sign Informed Consent.
  • Wear soft contact lenses for at least 3 months prior to the study.
  • Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks prior to enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in any clinical trial.
  • Regularly wear contact lenses on an extended/overnight basis.
  • Germany: pregnant or lactating.
  • Other protocol-defined inclusion/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: NCT01254747

Locations
United States, Georgia
CIBA VISION Research Clinic
Duluth, Georgia, United States, 30097
Germany
CIBA VISION Research Clinic
Grosswallstadt, Germany, 63868
Sponsors and Collaborators
CIBA VISION
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01254747     History of Changes
Other Study ID Numbers: P-347-C-003v2s2v2
Study First Received: December 3, 2010
Results First Received: April 18, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 24, 2014