Blepharitis
Conditions
Keywords
Meibomian gland dysfunction, Lid margin disease, doxycycline, azithromycin, essential fatty acid
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.
Detailed description
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.
Interventions
DRUGdoxycycline
Oral doxycycline 100mg bid
DRUGazithromycin
topical 1% azithromycin daily to eye
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Meibomian gland dysfunction
Exclusion criteria
* Lid margin scarring; herpetic blepharitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Response to Therapy | 4 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Doxycycline Oral doxycycline
doxycycline: Oral doxycycline 100mg bid | 9 |
| Azithromycin Topical azithromycin daily to the conjunctival culdesac
azithromycin: topical 1% azithromycin daily to eye | 22 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 3 |
Baseline characteristics
| Characteristic | Doxycycline | Azithromycin | Total |
|---|---|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 4 | 64 years STANDARD_DEVIATION 3 | 65 years STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 9 participants | 22 participants | 31 participants |
| Sex: Female, Male Female | 0 Participants | 10 Participants | 10 Participants |
| Sex: Female, Male Male | 9 Participants | 12 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 22 |
| other Total, other adverse events | 0 / 9 | 0 / 22 |
| serious Total, serious adverse events | 0 / 9 | 0 / 22 |
Outcome results
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.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxycycline | Global Response to Therapy | 16 eyes |
| Azithromycin | Global Response to Therapy | 41 eyes |
p-value: 0.001t-test, 2 sided