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
Results First Received: October 4, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Allergic Conjunctivitis
Interventions: Device: contact lens with ketotifen
Device: contact lens

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
K-Lens Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
Placebo Lens contact lens without drug

Participant Flow:   Overall Study
    K-Lens     Placebo Lens  
STARTED     168     82  
COMPLETED     161     78  
NOT COMPLETED     7     4  
Adverse Event                 2                 4  
Withdrawal by Subject                 3                 0  
Protocol Violation                 2                 0  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Lid and Lid Margin Erythema, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

2.  Primary:   Lid and Lid Margin Swelling, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

3.  Primary:   Conjunctival Redness, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

4.  Primary:   Conjunctival Chemosis, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

5.  Primary:   Corneal Edema, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

6.  Primary:   Corneal Erosion, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

7.  Primary:   Corneal Endothelial, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

8.  Primary:   Lens Pathology, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

9.  Primary:   Flare in Anterior Chamber, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

10.  Primary:   Cells in Anterior Chamber, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

11.  Primary:   Corneal Staining - Nasal, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

12.  Primary:   Corneal Staining - Temporal, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

13.  Primary:   Corneal Staining - Inferior, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

14.  Primary:   Corneal Staining - Superior, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

15.  Primary:   Corneal Staining - Central, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

16.  Primary:   Intraocular Pressure - Change From Baseline   [ Time Frame: baseline and 12 weeks ]

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

18.  Primary:   Dilated Ophthalmoscopy - Vitreous, Change From Baseline   [ Time Frame: baseline and 12 weeks ]

19.  Primary:   Visual Acuity Assessment   [ Time Frame: at the 12 week visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information