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

Phase 3

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Device: Placebo Lens; Device: K-Lens (generic name not established) and Ketotifen

• Registration Number: NCT00569777
• 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: 2007-10
• Study First Submitted: 2007-11-27
• Study First Submitted QC: 2007-12-06
• Study First Posted: 2007-12-07
• Primary Completion: 2008-02
• Study Completion: 2008-03
• 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: 310

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
Placebo	Placebo Lens	etafilcon A contact lens without ketotifen
K-lens	K-Lens (generic name not established) and Ketotifen	etafilcon A contact lens with ketotifen.

Primary Outcome Measures

Name	Time	Method
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.
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 redness of conjunctiva 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 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.
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.
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.
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.
Corneal Staining - Nasal, Change From Baseline	baseline and 12 weeks	Assessment of changes to the surface of 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 - Temporal, Change From Baseline	baseline and 12 weeks	Assessment of changes to the surface of the cornea, the region towards the outer 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.
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.
Corneal Staining - Superior, Change From Baseline	baseline and 12 weeks	Assessment of changes to the surface of the cornea, 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.
Corneal Staining - Central, Change From Baseline	baseline and 12 weeks	Assessment of changes to the surface of the cornea, 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
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.
Dilated Ophthalmoscopy - Vitreous, Change From Baseline	baseline and 12 weeks	Assessment of changes in the vitreous (gel-like fluid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.
Visual Acuity Assessment	at 12 weeks	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.