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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:
NCT00569777
First received: November 27, 2007
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;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Allergic Conjunctivitis
Interventions: Device: K-Lens (generic name not established) and Ketotifen
Device: Placebo 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
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Reporting Groups
  Description
K-lens etafilcon A contact lens with ketotifen.
Placebo etafilcon A contact lens without ketotifen

Participant Flow:   Overall Study
    K-lens     Placebo  
STARTED     206     104  
COMPLETED     196     101  
NOT COMPLETED     10     3  
Withdrawal by Subject                 4                 0  
Adverse Event                 3                 0  
Lost to Follow-up                 1                 0  
scheduled eye surgery                 0                 1  
did not meet exclusion criteria                 1                 2  
pregnant                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
K-lens etafilcon A contact lens with ketotifen.
Placebo etafilcon A contact lens without ketotifen
Total Total of all reporting groups

Baseline Measures
    K-lens     Placebo     Total  
Number of Participants  
[units: participants]
 		  206     104     310  
Age  
[units: years]
Mean ± Standard Deviation 		  31  ± 11.62     30  ± 10.75     31  ± 11.33  
Gender  
[units: participants]
 		     
Female     144     80     224  
Male     62     24     86  
Region of Enrollment  
[units: participants]
 		     
United States     206     104     310  



  Outcome Measures
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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 ]
  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 etafilcon A contact lens with ketotifen.
Placebo etafilcon A contact lens without ketotifen

Measured Values
    K-lens     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  181     104  
Number of eyes Analyzed  
[units: eyes]
 		  362     208  
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 ]
  Show Outcome Measure 3

4.  Primary:   Conjunctival Chemosis, Change From Baseline   [ Time Frame: baseline and 12 weeks ]
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5.  Primary:   Corneal Edema, Change From Baseline   [ Time Frame: baseline and 12 weeks ]
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6.  Primary:   Corneal Erosion, Change From Baseline   [ Time Frame: baseline and 12 weeks ]
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7.  Primary:   Corneal Endothelial, Change From Baseline   [ Time Frame: baseline and 12 weeks ]
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8.  Primary:   Lens Pathology, Change From Baseline   [ Time Frame: baseline and 12 weeks ]
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9.  Primary:   Flare in Anterior Chamber, Change From Baseline   [ Time Frame: baseline and 12 weeks ]
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10.  Primary:   Cells in Anterior Chamber, Change From Baseline   [ Time Frame: baseline and 12 weeks ]
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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 ]
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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 ]
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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 ]
  Show Outcome Measure 17

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 12 weeks ]
  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: NCT00569777     History of Changes
Other Study ID Numbers: 07-003-002
Study First Received: November 27, 2007
Results First Received: October 4, 2010
Last Updated: September 26, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board