Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Study of an Investigational Daily Disposable Contact Lens

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.
 
ClinicalTrials.gov Identifier: NCT01295905
Recruitment Status : Completed
First Posted : February 15, 2011
Results First Posted : June 20, 2012
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.

Condition or disease Intervention/treatment Phase
Myopia Device: delefilcon A contact lens Device: narafilcon B contact lens Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : January 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: delefilcon A
Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
 Device: delefilcon A contact lens
Investigational silicone hydrogel, single vision soft contact lens
Active Comparator: narafilcon B
Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
 Device: narafilcon B contact lens
Commercially marketed silicone hydrogel, single vision soft contact lens


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity [ Time Frame: 3 months of wear, lenses replaced daily ]
    Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.


Secondary Outcome Measures :
  1. Overall Vision [ Time Frame: 3 months of wear, lenses replaced daily ]
    As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

  2. Overall Comfort [ Time Frame: 3 months of wear, lenses replaced daily ]
    As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

  3. Overall Handling [ Time Frame: 3 months of wear, lenses replaced daily ]
    As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with normal eyes who are not using any ocular medications.
  • Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
  • Willing and able to wear spherical contact lenses for at least 5 days per week.
  • Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps.
  • Best spectacle-corrected visual acuity greater than or equal to 20/25.
  • Manifest cylinder less than or equal to 0.75D.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any active anterior segment ocular disease that would contraindicate contact lens wear.
  • Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
  • History of refractive surgery or irregular cornea.
  • History of pathologically dry eye.
  • Eye injury within twelve weeks immediately prior to enrollment for this trial.
  • Currently enrolled in any clinical trial.
  • Participation in a contact lens or contact lens care product clinical trial within the previous 30 days.
  • Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01295905    
Other Study ID Numbers: P-347-C-004
First Posted: February 15, 2011    Key Record Dates
Results First Posted: June 20, 2012
Last Update Posted: July 10, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Myopia
Refractive Errors
Eye Diseases