Text Size

Clinical Evaluation of Ocular Responses With Contact Lens Wear

This study has been completed.
Sponsor:
Collaborator:
Coles-Brennan Pty Ltd
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01444287
First received: September 27, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

The purpose of this research is to compare the ocular responses subjects have to three soft contact lens designs and spectacles.


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

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

Resource links provided by NLM:

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

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 ]
  • Endothelial Bleb [ Time Frame: After 20 minutes of contact lens wear ] [ Designated as safety issue: No ]
  • Limbal Redness [ Time Frame: After 8 hours of contact lens wear ] [ Designated as safety issue: No ]

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
No Intervention: 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
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
Coles-Brennan Pty Ltd
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
Last Updated: September 27, 2011
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013