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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
K-Lens Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
Placebo Lens contact lens without drug
Total Total of all reporting groups

Baseline Measures
    K-Lens     Placebo Lens     Total  
Number of Participants  
[units: participants]
  168     82     250  
Age  
[units: years]
Mean ± Standard Deviation
  32.6  ± 12.48     29.3  ± 10.77     31.5  ± 12.03  
Gender  
[units: participants]
     
Female     117     46     163  
Male     51     36     87  
Region of Enrollment  
[units: participants]
     
United States     168     82     250  



  Outcome Measures
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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 ]
  Hide Outcome Measure 2

Measure Type Primary
Measure Title Lid and Lid Margin Swelling, Change From Baseline
Measure Description Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Time Frame baseline and 12 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects that completed the study per protocol were included in this analysis.

Reporting Groups
  Description
K-Lens Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
Placebo Lens contact lens without drug

Measured Values
    K-Lens     Placebo Lens  
Number of Participants Analyzed  
[units: participants]
  158     75  
Number of eyes Analyzed  
[units: eyes]
  316     150  
Lid and Lid Margin Swelling, Change From Baseline  
[units: Units on a scale]
Mean ± Standard Deviation
  0  ± 0     0  ± 0  

No statistical analysis provided for Lid and Lid Margin Swelling, Change From Baseline



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