Daytime Corneal Swelling During Wear of Narafilcon B Lenses

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

Conditions
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Myopia

Intervention / Treatment
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* Device: narafilcon B
* Device: Polymacon
* Device: Lotrafilcon A
* Other: Spectacles


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Spectacles No Lenses<br>Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. | Other: Spectacles<br>* None - subject used own spectacles<br>|
| Experimental: narafilcon B<br>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<br>* test product<br>|
| Active Comparator: polymacon<br>Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. | Device: Polymacon<br>* marketed product<br>|
| Active Comparator: lotrafilcon A<br>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<br>* marketed product<br>|

What is the study measuring?
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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 |