Daytime Corneal Swelling During Wear of Narafilcon B Lenses

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444287
• Other study ID #: CR-0918 (JKN 0927)
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: March 2010

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• narafilcon B
test product
• Polymacon
marketed product
• Lotrafilcon A
marketed product

Other:
• Spectacles
None - subject used own spectacles

Locations

Country	Name	City	State
Australia	Coles-Brennan Pty Ltd	Hawthorn	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Overall Comfort	Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best).	after 8 hours