Daytime Corneal Swelling During Wear of Narafilcon B Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01444287
First received: September 27, 2011
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.


Condition Intervention
Myopia
Device: narafilcon B
Device: Polymacon
Device: Lotrafilcon A
Other: Spectacles

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Corneal Thickness [ Time Frame: After 8 hours of contact lens wear ] [ Designated as safety issue: No ]
    Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.

  • Endothelial Blebs [ Time Frame: baseline, after 20 minutes of treatment conditions ] [ Designated as safety issue: No ]
    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).

  • Limbal Redness [ Time Frame: Baseline, After 8 hours of treatment conditions ] [ Designated as safety issue: No ]
    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:
  • Overall Comfort [ Time Frame: after 8 hours ] [ Designated as safety issue: No ]
    Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best).


Enrollment: 22
Study Start Date: January 2010
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: NCT01444287

Locations
Australia, Victoria
Coles-Brennan Pty Ltd
Hawthorn, Victoria, Australia
Sponsors and Collaborators
Vistakon
Investigators
Principal Investigator: Noel Brennan, McOptom PhD Coles-Brennan Pty Ltd
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01444287     History of Changes
Other Study ID Numbers: CR-0918 (JKN 0927)
Study First Received: September 27, 2011
Results First Received: March 27, 2014
Last Updated: April 30, 2014
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 23, 2014