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Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine

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ClinicalTrials.gov Identifier: NCT01942486
Recruitment Status : Terminated
First Posted : September 16, 2013
Results First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Primary Children's Hospital
Information provided by (Responsible Party):
Bradley Katz, University of Utah

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Migraine Disorders
Photophobia
Intervention Device: Investigational Coating
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Investigational Coating
Hide Arm/Group Description Subjects will be randomized to wear an investigational coating on their glasses
Period Title: Overall Study
Started 35
Completed 8
Not Completed 27
Reason Not Completed
Lost to Follow-up             27
Arm/Group Title Investigational Coating
Hide Arm/Group Description Investigational Coating
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
<=18 years
35
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
13  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
20
  57.1%
Male
15
  42.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
35
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
1.Primary Outcome
Title HIT-6 Score
Hide Description The HIT-6 (Headache Impact Test) is a validated measure of the impact of headache on activities of daily living, functional health and well-being. The minimum score is 36 and the maximum score is 78. The higher the score, the more your headaches are adversely affecting activities of daily living. Patients who score higher than 50 are encouraged to seek help from their physician.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects that completed the trial were analyzed
Arm/Group Title Investigational Coating
Hide Arm/Group Description:
Subjects will wear an investigational coating on their eyeglasses to reduce headache frequency
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
62.3  (4.8)
Time Frame 3 years
Adverse Event Reporting Description This was a minimal risk study with no risk of mortality and no risk of a serious adverse even
 
Arm/Group Title Investigational Coating
Hide Arm/Group Description Subjects were asked to wear an investigational coating on their eyeglasses to reduce their headache severity
All-Cause Mortality
Investigational Coating
Affected / at Risk (%)
Total   0/35 (0.00%) 
Hide Serious Adverse Events
Investigational Coating
Affected / at Risk (%)
Total   0/35 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Investigational Coating
Affected / at Risk (%)
Total   0/35 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bradley Katz
Organization: University of Utah
Phone: 8015871079
EMail: bradley.katz@hsc.utah.edu
Layout table for additonal information
Responsible Party: Bradley Katz, University of Utah
ClinicalTrials.gov Identifier: NCT01942486    
Other Study ID Numbers: IRB_00065178
First Submitted: June 14, 2013
First Posted: September 16, 2013
Results First Submitted: April 12, 2019
Results First Posted: March 26, 2020
Last Update Posted: March 26, 2020