Daytime Corneal Swelling During Wear of Narafilcon B Lenses

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Other: Spectacles; Device: narafilcon B; Device: Polymacon; Device: Lotrafilcon A

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Hawthorn, Victoria, Australia
      • Coles-Brennan Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Thickness	Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.	After 8 hours of contact lens wear
Endothelial Blebs	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).	baseline, after 20 minutes of treatment conditions
Limbal Redness	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.	Baseline, After 8 hours of treatment conditions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Comfort	Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best).	after 8 hours

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Investigators: Principal Investigator: Noel Brennan, McOptom PhD, Coles-Brennan Pty Ltd

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: September 27, 2011
• First Submitted That Met QC Criteria: September 27, 2011
• First Posted (Estimate): September 30, 2011

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-0918 (JKN 0927)