Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers.

Official Title
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A Single-Center, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Evaluating the Safety of a Novel Contact Lens Used Daily in Healthy, Normal Volunteers

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Device: contact lens with ketotifen
* Device: contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy normal, soft contact lens wearing volunteers normal ocular health contact lens correction from +6.00 to -12.00D in each eye and astigmatism of -1.00D or less in each eye Exclusion Criteria: active ocular infection history of ocular surgery use of topical ophthalmic preparations (including rewetting drops) pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K-Lens<br>Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug | Device: contact lens with ketotifen<br>* K-Lens (generic name not established) and Ketotifen combination drug-device product<br>|
| Placebo Comparator: Placebo Lens<br>Placebo lens | Device: contact lens<br>* Placebo contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lid and Lid Margin Erythema, Change From Baseline | Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Lid and Lid Margin Swelling, Change From Baseline | Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Conjunctival Redness, Change From Baseline | Assessment of conjunctival redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Conjunctival Chemosis, Change From Baseline | Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Corneal Edema, Change From Baseline | Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Corneal Erosion, Change From Baseline | Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Corneal Endothelial, Change From Baseline | Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Lens Pathology, Change From Baseline | Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Flare in Anterior Chamber, Change From Baseline | Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Cells in Anterior Chamber, Change From Baseline | Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Corneal Staining - Nasal, Change From Baseline | Assessment of changes to the surface of the cornea, the region towards the nose, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Corneal Staining - Temporal, Change From Baseline | Assessment of changes to the surface of the cornea, the region towards the edge of the face, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Corneal Staining - Inferior, Change From Baseline | Assessment of changes to the surface of the cornea, the bottom region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Corneal Staining - Superior, Change From Baseline | Assessment of changes to the surface of the cornea, the upper region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Corneal Staining - Central, Change From Baseline | Assessment of changes to the surface of the cornea, the central region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | baseline and 12 weeks | 
| Intraocular Pressure - Change From Baseline |  | baseline and 12 weeks | 
| Dilated Ophthalmoscopy - Fundus, Change From Baseline | Assessment of changes in abnormalities on the back part of the eye, using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe. | baseline and 12 weeks | 
| Dilated Ophthalmoscopy - Vitreous, Change From Baseline | Assessment of changes in the vitreous (gel-like fulid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe. | baseline and 12 weeks | 
| Visual Acuity Assessment | Visual acuity was assessed by the investigator using a Snellen visual acuity chart. This outcome counts the number of eyes that had vision of 20/40 or better at the 12 week visit. | at the 12 week visit |