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| Sponsor: | University of Louisville |
|---|---|
| Information provided by: | University of Louisville |
| ClinicalTrials.gov Identifier: | NCT00803452 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Blepharitis |
Drug: doxycycline Drug: essential fatty acid Drug: azithromycin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Lipids of the Human Tear Film and Their Effect on Tear Stability |
| Estimated Enrollment: | 400 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Doxycycline
Oral doxycycline
|
Drug: doxycycline
Oral doxycycline 100mg bid
Other Name: Minocycline
|
|
Active Comparator: essential fatty acid
Oral essential fatty acid
|
Drug: essential fatty acid
Oral essential fatty acid 1000mg per day
Other Name: Fish Oil; Flax Seed Oil
|
|
Active Comparator: azithromycin
Topical azithromycin daily to the conjunctival culdesac
|
Drug: azithromycin
topical 1% azithromycin daily to eye
Other Name: Azasite
|
Subjects with meibomian gland dysfunction undergo expression of the meibomian gland secretion prior to beginning treatment with either oral doxycycline, oral essential fatty acids, or topical azithromycin solution. Doxycycline is dosed at 100 mg bid; essential fatty acid is dosed at 1000 mg per day; topical azithromycin is delivered once per day as a 1% solution. Treatment with doxycycline is for two months; treatment with essential fatty acids is for two months; treatment with topical azithromycin is for one month. Following treatment, meibomian glands are again expressed and the lipids measured by spectroscopy (FTIR, MALDI-TOF, NMR)for characterization of structure and function. Analysis for presence of doxcycline or azithromycin is also performed. Changes in lipid parameters are correlated with clinical signs and symptoms of disease.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Gary N Foulks, MD | 502-852-6150 | gnfoul01@louisville.edu |
| Contact: Douglas Borchman, PhD | 502-852-7435 | borchman@louisville.edu |
| United States, Kentucky | |
| Kentucky Lions Eye Center | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Gary N Foulks, MD 502-852-6150 gnfoul01@louisville.edu | |
| Principal Investigator: Gary N Foulks, MD | |
| Principal Investigator: | Gary N Foulks, MD | University of Louisville |
More Information
| Responsible Party: | Gary N. Foulks, MD, University of Louisville |
| ClinicalTrials.gov Identifier: | NCT00803452 History of Changes |
| Other Study ID Numbers: | lipidtearfilm, NEI RO-1- EY017094-02 |
| Study First Received: | December 1, 2008 |
| Last Updated: | November 23, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Meibomian gland dysfunction Lid margin disease doxycycline azithromycin essential fatty acid |
|
Blepharitis Eyelid Diseases Eye Diseases Doxycycline Doxycycline hyclate Minocycline Azithromycin |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents |
