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

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

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

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Device: contact lens with ketotifen; Device: contact lens

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vistakon Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: April 24, 2009
• First Submitted That Met QC Criteria: April 27, 2009
• First Posted (Estimate): April 28, 2009

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: February 18, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Ketotifen
• Other Study ID Numbers: CR-4539