Lipids of the Human Tear Film and Their Effect on Tear Stability
2 other identifiers
interventional
31
1 country
1
Brief Summary
This prospective, randomized, comparative clinical trial evaluates the effect of either oral doxycycline, oral essential fatty acid, or topical azithromycin to modify the secretions of the meibomian gland in subjects with meibomian gland dysfunction and/or dry eye disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 1, 2008
CompletedFirst Posted
Study publicly available on registry
December 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
December 22, 2017
CompletedDecember 22, 2017
November 1, 2017
2.4 years
December 1, 2008
April 7, 2017
November 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Global Response to Therapy
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.
4 weeks
Study Arms (2)
Doxycycline
ACTIVE COMPARATOROral doxycycline
azithromycin
ACTIVE COMPARATORTopical azithromycin daily to the conjunctival culdesac
Interventions
Eligibility Criteria
You may qualify if:
- Meibomian gland dysfunction
You may not qualify if:
- Lid margin scarring; herpetic blepharitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kentucky Lions Eye Center
Louisville, Kentucky, 40202, United States
Related Publications (3)
Foulks GN, Borchman D, Yappert M, Kakar S. Topical azithromycin and oral doxycycline therapy of meibomian gland dysfunction: a comparative clinical and spectroscopic pilot study. Cornea. 2013 Jan;32(1):44-53. doi: 10.1097/ICO.0b013e318254205f.
PMID: 22668581RESULTFoulks GN, Borchman D, Yappert M, Kim SH, McKay JW. Topical azithromycin therapy for meibomian gland dysfunction: clinical response and lipid alterations. Cornea. 2010 Jul;29(7):781-8. doi: 10.1097/ICO.0b013e3181cda38f.
PMID: 20489573RESULTBorchman D, Foulks GN, Yappert MC, Bell J, Wells E, Neravetla S, Greenstone V. Human meibum lipid conformation and thermodynamic changes with meibomian-gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Jun 1;52(6):3805-17. doi: 10.1167/iovs.10-6514.
PMID: 21398284DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor Douglas Borchman
- Organization
- University of Louisville
Study Officials
- PRINCIPAL INVESTIGATOR
Gary N Foulks, MD
University of Louisville
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 1, 2008
First Posted
December 5, 2008
Study Start
July 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
December 22, 2017
Results First Posted
December 22, 2017
Record last verified: 2017-11