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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
History of Changes
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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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
  Show All Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Measure Type Primary
Measure Title Dilated Ophthalmoscopy - Fundus, Change From Baseline
Measure Description 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.
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  
Dilated Ophthalmoscopy - Fundus, Change From Baseline  
[units: Units on a scale]
Mean ± Standard Deviation 		  0  ± 0     0  ± 0  

No statistical analysis provided for Dilated Ophthalmoscopy - Fundus, Change From Baseline



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

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


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Brian Pall OD MS FAAO
Organization: Vistakon
phone: 904-443-1290


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