Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NEI RO-1- EY017094-02 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Subjects with meibomian gland dysfunction undergo expression of the meibomian gland secretion prior to beginning treatment with either oral doxycycline or topical azithromycin solution. Doxycycline is dosed at 100 mg bid; topical azithromycin is delivered once per day as a 1% solution. Treatment with doxycycline 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxycycline | Active Comparator | Oral doxycycline |
|
| azithromycin | Active Comparator | Topical azithromycin daily to the conjunctival culdesac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxycycline | Drug | Oral doxycycline 100mg bid |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gary N Foulks, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kentucky Lions Eye Center | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22668581 | Result | 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. | |
| 20489573 | Result | Foulks 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Doxycycline | Oral doxycycline doxycycline: Oral doxycycline 100mg bid |
| FG001 | Azithromycin | Topical azithromycin daily to the conjunctival culdesac azithromycin: topical 1% azithromycin daily to eye |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Doxycycline | Oral doxycycline doxycycline: Oral doxycycline 100mg bid |
| BG001 | Azithromycin | Topical azithromycin daily to the conjunctival culdesac azithromycin: topical 1% azithromycin daily to eye |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | eyes | 4 weeks | eyes | eyes |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Doxycycline | Oral doxycycline doxycycline: Oral doxycycline 100mg bid | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Douglas Borchman | University of Louisville | 502 852 7435 | borchman@louisville.edu |
Not provided
| ID | Term |
|---|---|
| D001762 | Blepharitis |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D008911 | Minocycline |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| azithromycin | Drug | topical 1% azithromycin daily to eye |
|
|
| 21398284 | Derived | Borchman 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Azithromycin | Topical azithromycin daily to the conjunctival culdesac azithromycin: topical 1% azithromycin daily to eye | 0 | 22 | 0 | 22 | 0 | 22 |
Not provided
Not provided
Not provided
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |