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Trial record 2 of 5 for:    ketotifen contact lens

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

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ClinicalTrials.gov Identifier: NCT00569777
Recruitment Status : Completed
First Posted : December 7, 2007
Results First Posted : November 23, 2010
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 27, 2007
First Posted Date  ICMJE December 7, 2007
Results First Submitted Date  ICMJE October 4, 2010
Results First Posted Date  ICMJE November 23, 2010
Last Update Posted Date March 6, 2015
Study Start Date  ICMJE October 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2010)
  • 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.
  • 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.
  • Conjunctival Redness, Change From Baseline [ Time Frame: 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 [ 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Corneal Staining - Nasal, Change From Baseline [ Time Frame: 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 [ Time Frame: 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 [ 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.
  • Corneal Staining - Superior, Change From Baseline [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline and 12 weeks ]
  • 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.
  • Dilated Ophthalmoscopy - Vitreous, Change From Baseline [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2007)
Adverse events, biomicroscopy, visual acuity, ophthalmoscopy and intraocular pressure, physical exam, pupil reactivity [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
Official Title  ICMJE A Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Evaluating the Safety of a Novel Contact Lens Used Daily in Healthy, Normal Volunteers
Brief Summary The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Allergic Conjunctivitis
Intervention  ICMJE
  • Device: K-Lens (generic name not established) and Ketotifen
    combination drug-device product: contact lens (device) and anti-allergy drug
  • Device: Placebo Lens
    contact lens without drug
Study Arms  ICMJE
  • Experimental: K-lens
    etafilcon A contact lens with ketotifen.
    Intervention: Device: K-Lens (generic name not established) and Ketotifen
  • Placebo Comparator: Placebo
    etafilcon A contact lens without ketotifen
    Intervention: Device: Placebo Lens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2010)
310
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2007)
300
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00569777
Other Study ID Numbers  ICMJE 07-003-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vistakon Pharmaceuticals
Study Sponsor  ICMJE Vistakon Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Brian Pall, OD, MS, FAAO Johnson & Johnson Vision Care, Inc.
PRS Account Vistakon Pharmaceuticals
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP