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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00889252
Recruitment Status : Completed
First Posted : April 28, 2009
Results First Posted : November 23, 2010
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Device: contact lens with ketotifen Device: contact lens Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2009
Actual Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Lid and Lid Margin Erythema, Change From Baseline [ Time Frame: baseline and 12 weeks ]
    Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe

  2. Lid and Lid Margin Swelling, Change From Baseline [ Time Frame: baseline and 12 weeks ]
    Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe

  3. Conjunctival Redness, Change From Baseline [ Time Frame: baseline and 12 weeks ]
    Assessment of conjunctival redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe

  4. Conjunctival Chemosis, Change From Baseline [ Time Frame: 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

  5. Corneal Edema, Change From Baseline [ Time Frame: baseline and 12 weeks ]
    Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe

  6. Corneal Erosion, Change From Baseline [ Time Frame: baseline and 12 weeks ]
    Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe

  7. Corneal Endothelial, Change From Baseline [ Time Frame: baseline and 12 weeks ]
    Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe

  8. Lens Pathology, Change From Baseline [ Time Frame: 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

  9. Flare in Anterior Chamber, Change From Baseline [ Time Frame: 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

  10. Cells in Anterior Chamber, Change From Baseline [ Time Frame: 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

  11. Corneal Staining - Nasal, Change From Baseline [ Time Frame: 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

  12. Corneal Staining - Temporal, Change From Baseline [ Time Frame: 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

  13. Corneal Staining - Inferior, Change From Baseline [ Time Frame: 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

  14. Corneal Staining - Superior, Change From Baseline [ Time Frame: 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

  15. Corneal Staining - Central, Change From Baseline [ Time Frame: 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

  16. Intraocular Pressure - Change From Baseline [ Time Frame: baseline and 12 weeks ]
  17. Dilated Ophthalmoscopy - Fundus, Change From Baseline [ Time Frame: 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.

  18. Dilated Ophthalmoscopy - Vitreous, Change From Baseline [ Time Frame: 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.

  19. Visual Acuity Assessment [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00889252


Locations
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United States, Tennessee
Memphis, Tennessee, United States
Sponsors and Collaborators
Vistakon Pharmaceuticals
Investigators
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Study Director: Brian Pall, OD, MS, FAAO Johnson & Johnson Vision Care, Inc.
More Information
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Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00889252    
Other Study ID Numbers: CR-4539
First Posted: April 28, 2009    Key Record Dates
Results First Posted: November 23, 2010
Last Update Posted: March 6, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ketotifen
Antipruritics
 Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents