Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers - Full Text View

Purpose

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

Condition	Intervention	Phase
Allergic Conjunctivitis	Device: contact lens with ketotifen Device: contact lens	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Edema Eye Wear Pinkeye

Drug Information available for: Ketotifen Ketotifen fumarate

U.S. FDA Resources

Further study details as provided by Vistakon Pharmaceuticals:

Primary Outcome Measures:

Lid and Lid Margin Erythema, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Conjunctival Redness, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
Assessment of conjunctival redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Conjunctival Chemosis, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Corneal Erosion, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Corneal Endothelial, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 - Temporal, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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
Corneal Staining - Inferior, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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
Corneal Staining - Central, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
Dilated Ophthalmoscopy - Fundus, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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.
Visual Acuity Assessment [ Time Frame: at the 12 week visit ] [ Designated as safety issue: Yes ]
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.

Enrollment:	250
Study Start Date:	April 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889252

Locations

United States, Tennessee

Memphis, Tennessee, United States

Sponsors and Collaborators

Vistakon Pharmaceuticals

Investigators

Study Director:

Brian Pall, OD, MS, FAAO

Vistakon

More Information

No publications provided

Responsible Party:	Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00889252 History of Changes
Other Study ID Numbers:	CR-4539
Study First Received:	April 24, 2009
Results First Received:	October 4, 2010
Last Updated:	September 26, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ketotifen
Antipruritics
Dermatologic Agents

Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents

ClinicalTrials.gov processed this record on June 18, 2013