We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Daytime Corneal Swelling During Wear of Narafilcon B Lenses

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: NCT01444287
Recruitment Status : Completed
First Posted : September 30, 2011
Results First Posted : May 30, 2014
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.

Condition or disease Intervention/treatment
Myopia Device: narafilcon B Device: Polymacon Device: Lotrafilcon A Other: Spectacles

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2010
Primary Completion Date : February 2010
Study Completion Date : March 2010
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Spectacles No Lenses
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
Other: Spectacles
None - subject used own spectacles
Experimental: narafilcon B
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
Device: narafilcon B
test product
Active Comparator: polymacon
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
Device: Polymacon
marketed product
Active Comparator: lotrafilcon A
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
Device: Lotrafilcon A
marketed product


Outcome Measures

Primary Outcome Measures :
  1. Corneal Thickness [ Time Frame: After 8 hours of contact lens wear ]
    Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.

  2. Endothelial Blebs [ Time Frame: baseline, after 20 minutes of treatment conditions ]
    Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline).

  3. Limbal Redness [ Time Frame: Baseline, After 8 hours of treatment conditions ]
    Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported.


Secondary Outcome Measures :
  1. Overall Comfort [ Time Frame: after 8 hours ]
    Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best).


Eligibility Criteria

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be of legal age (i.e. ≥ 18 years).
  • Be mentally competent, willing and able to sign a written informed consent form.
  • Have contact lens distance sphere requirement in the range -1.00D to -6.00D.
  • Have spectacle astigmatism <1.25D in each eye.
  • Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription.
  • Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease.

Exclusion Criteria:

  • Required concurrent ocular medication.
  • Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
  • Abnormal lacrimal secretions.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Keratoconus or other corneal irregularity.
  • Pregnancy, lactating or planning a pregnancy at the time of enrollment.
  • Participation in any concurrent clinical trial.
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): NCT01444287


Locations
Australia, Victoria
Coles-Brennan Pty Ltd
Hawthorn, Victoria, Australia
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
Investigators
Principal Investigator: Noel Brennan, McOptom PhD Coles-Brennan Pty Ltd
More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01444287     History of Changes
Other Study ID Numbers: CR-0918 (JKN 0927)
First Posted: September 30, 2011    Key Record Dates
Results First Posted: May 30, 2014
Last Update Posted: May 21, 2015
Last Verified: May 2015