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

Phase 3

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Device: contact lens with ketotifen; Device: contact lens

• Registration Number: NCT00889252
• Lead Sponsor: Vistakon Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-27
• Study First Posted: 2009-04-28
• Primary Completion: 2009-07
• Results First Submitted: 2010-10-04
• Results First Submitted QC: 2010-10-26
• Results First Posted: 2010-11-23
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-18
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
K-Lens	contact lens with ketotifen	Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
Placebo Lens	contact lens	Placebo lens

Primary Outcome Measures

Name	Time	Method
Corneal Edema, Change From Baseline	baseline and 12 weeks	Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Corneal Erosion, Change From Baseline	baseline and 12 weeks	Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Corneal Staining - Superior, Change From Baseline	baseline and 12 weeks	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
Cells in Anterior Chamber, Change From Baseline	baseline and 12 weeks	Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Dilated Ophthalmoscopy - Vitreous, Change From Baseline	baseline and 12 weeks	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.
Lid and Lid Margin Erythema, Change From Baseline	baseline and 12 weeks	Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Corneal Staining - Central, Change From Baseline	baseline and 12 weeks	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
Intraocular Pressure - Change From Baseline	baseline and 12 weeks
Lid and Lid Margin Swelling, Change From Baseline	baseline and 12 weeks	Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Conjunctival Redness, Change From Baseline	baseline and 12 weeks	Assessment of conjunctival redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Flare in Anterior Chamber, Change From Baseline	baseline and 12 weeks	Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Corneal Staining - Temporal, Change From Baseline	baseline and 12 weeks	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
Conjunctival Chemosis, Change From Baseline	baseline and 12 weeks	Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Corneal Endothelial, Change From Baseline	baseline and 12 weeks	Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Lens Pathology, Change From Baseline	baseline and 12 weeks	Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Corneal Staining - Nasal, Change From Baseline	baseline and 12 weeks	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
Corneal Staining - Inferior, Change From Baseline	baseline and 12 weeks	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
Dilated Ophthalmoscopy - Fundus, Change From Baseline	baseline and 12 weeks	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.
Visual Acuity Assessment	at the 12 week visit	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.