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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00889252
First received: April 24, 2009
Last updated: September 26, 2011
Last verified: September 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014