Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482819
• Other study ID #: CR-005031
• Status: Completed
• Phase: N/A
• Start date: October 1, 2011
• Est. completion date: December 1, 2011

Study information

• Verified date: August 2017
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 1, 2011
• Est. primary completion date: December 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be of legal age (i.e. 18 years)

• Be of Asian descent and have ?Asian eye? identifying features (see Appendix A)

• 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 3 months prior to the trial ) without experiencing difficulties or contact lens related complications

• Have had an oculo-visual examination within the previous 12 months.

• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

• No evidence of lid abnormality or infection

• No conjunctival abnormality or infection

• No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularization, infiltrates or abnormal opacities)

• No other active ocular disease

Exclusion Criteria:

• Requires concurrent ocular medication.

• Clinically significant (Grade 3 or 4) corneal staining (FDA scale), corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.

• Has had refractive surgery.

• Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrolment for this study.

• History of abnormal lachrymal secretions.

• Pre-existing ocular irritation that would preclude contact lens fitting.

• Keratoconus or other corneal irregularity.

• Extended lens wear in last 3 months.

• PMMA, hybrid or RGP lens wear in the previous 8 weeks

• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.

• Has diabetes

• Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).

• History of chronic eye disease (e.g. glaucoma or ARMD).

• Pregnancy, lactating, or planning a pregnancy at the time of enrolment.

• Participation in any concurrent clinical trial or in last 30 days.

• Family member or employee of the clinical site, investigator or other study staff.

• Currently wears habitual contact lenses on an EW basis.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• galyfilcon A
contact lenses worn bilaterally for 8-12 hours
• galyfilcon A plus
contact lenses worn bilaterally for 8-12 hours
• lotrafilcon A
contact lenses worn bilaterally for 8-12 hours
• polymacon
contact lenses worn bilaterally for 8-12 hours

Other:
• spectacles
habitual spectacles owned by subject, non-specific manufacturer

Locations

Country	Name	City	State
n/a

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 Swelling	measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm)	after 8 hours of lens wear
Primary	Limbal Redness	grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.	after 8 hours of lens wear
Primary	Endothelia Blebs	0 to 100% of area; measured as a percentage of corneal area with blebs.	after 20 minutes of lens wear