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Lipids of the Human Tear Film and Their Effect on Tear Stability

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ClinicalTrials.gov Identifier: NCT00803452
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Douglas Bourchman, University of Louisville

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Blepharitis
Interventions Drug: doxycycline
Drug: azithromycin
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Doxycycline Azithromycin
Hide Arm/Group Description

Oral doxycycline

doxycycline: Oral doxycycline 100mg bid

Topical azithromycin daily to the conjunctival culdesac

azithromycin: topical 1% azithromycin daily to eye

Period Title: Overall Study
Started 9 22
Completed 9 17
Not Completed 0 5
Reason Not Completed
Adverse Event             0             2
Lost to Follow-up             0             3
Arm/Group Title Doxycycline Azithromycin Total
Hide Arm/Group Description

Oral doxycycline

doxycycline: Oral doxycycline 100mg bid

Topical azithromycin daily to the conjunctival culdesac

azithromycin: topical 1% azithromycin daily to eye

Total of all reporting groups
Overall Number of Baseline Participants 9 22 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 22 participants 31 participants
68  (4) 64  (3) 65  (3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 22 participants 31 participants
Female
0
   0.0%
10
  45.5%
10
  32.3%
Male
9
 100.0%
12
  54.5%
21
  67.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 22 participants 31 participants
9 22 31
1.Primary Outcome
Title Global Response to Therapy
Hide Description Global Response to Therapy (itch, dryness, burning and swelling of eyes) as assessed with a questionnaire completed by the subjects. The questionnaire asked subjects to rate their improvement on a scale from 4 to 0 with 4 being resolution of symptoms and 0 being no improvement. Data reported here represent the number of eye of subjects that reported that their symptoms were resolved or improved in each eye.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Azithromycin
Hide Arm/Group Description:

Oral doxycycline

doxycycline: Oral doxycycline 100mg bid

Topical azithromycin daily to the conjunctival culdesac

azithromycin: topical 1% azithromycin daily to eye

Overall Number of Participants Analyzed 9 22
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
18 44
Measure Type: Number
Unit of Measure: eyes
16 41
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline, Azithromycin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Doxycycline Azithromycin
Hide Arm/Group Description

Oral doxycycline

doxycycline: Oral doxycycline 100mg bid

Topical azithromycin daily to the conjunctival culdesac

azithromycin: topical 1% azithromycin daily to eye

All-Cause Mortality
Doxycycline Azithromycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/22 (0.00%) 
Hide Serious Adverse Events
Doxycycline Azithromycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Doxycycline Azithromycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/22 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Douglas Borchman
Organization: University of Louisville
Phone: 502 852 7435
EMail: borchman@louisville.edu
Layout table for additonal information
Responsible Party: Douglas Bourchman, University of Louisville
ClinicalTrials.gov Identifier: NCT00803452    
Other Study ID Numbers: lipidtearfilm
NEI RO-1- EY017094-02
First Submitted: December 1, 2008
First Posted: December 5, 2008
Results First Submitted: April 7, 2017
Results First Posted: December 22, 2017
Last Update Posted: December 22, 2017