A Phase 4 interventional study of doxycycline and azithromycin in Blepharitis, sponsored by University of Louisville. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-22.
Sponsored by University of Louisville · Phase 4, Interventional, and Treatment
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.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 31 is below the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →University of Louisville is the lead sponsor of 291 studies on the registry; 54 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 7 (37%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Oral doxycycline
Drug: doxycycline
Topical azithromycin daily to the conjunctival culdesac
Drug: azithromycin
Oral doxycycline 100mg bid
Also known as: Minocycline
topical 1% azithromycin daily to eye
Also known as: Azasite
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.
Time frame: 4 weeks
| Milestone | Doxycycline | Azithromycin |
|---|---|---|
| Started | 9 | 22 |
| Completed | 9 | 17 |
| Not completed | 0 | 5 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 3 |
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.
| eyes | Doxycycline | Azithromycin |
|---|---|---|
| Global Response to Therapy | 16 | 41 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Doxycycline | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Azithromycin | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Continuous(years) | Doxycycline | Azithromycin | Total |
|---|---|---|---|
| Mean | 68 ± 4 | 64 ± 3 | 65 ± 3 |
| Sex: Female, Male(Participants) | Doxycycline | Azithromycin | Total |
|---|---|---|---|
| Female | 0 | 10 | 10 |
| Male | 9 | 12 | 21 |
| Region of Enrollment(participants) | Doxycycline | Azithromycin | Total |
|---|---|---|---|
| United States | 9 | 22 | 31 |
The record gives a start of Jul 2008, a primary completion of Dec 2010 and a completion of Dec 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2017, 7 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Doxycycline · Azithromycin