Trial Outcomes & Findings for Azithromycin for Meibomian Gland Disease (NCT NCT03953118)

Results Overview

Ocular surface disease index - used to evaluate the degree of dry eye symptoms. Scores will range from 0 to 48, where 48 indicates severe dry eye.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

Baseline to 1 month

Results posted on

2025-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo Oral: Oral placebo tablet	Azithromycin Azithromycin Oral Product: Oral azithromycin dosed at 1 gram per week for 3 weeks
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo Oral: Oral placebo tablet	Azithromycin Azithromycin Oral Product: Oral azithromycin dosed at 1 gram per week for 3 weeks
Overall Study Study terminated due to lack of funding prior to data collection for for outcomes and adverse events	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=1 Participants Placebo Oral: Oral placebo tablet	Azithromycin n=1 Participants Azithromycin Oral Product: Oral azithromycin dosed at 1 gram per week for 3 weeks	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants
Age, Categorical >=65 years	1 Participants n=1 Participants	1 Participants n=1 Participants	2 Participants n=2 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	1 Participants n=1 Participants	2 Participants n=2 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Baseline to 1 month

Population: Study terminated prior to data collection for outcomes. No data were collected for this outcome measure.

Ocular surface disease index - used to evaluate the degree of dry eye symptoms. Scores will range from 0 to 48, where 48 indicates severe dry eye.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: Study terminated prior to data collection for outcomes. No data were collected for this outcome measure.

Ocular surface disease index - used to evaluate the degree of dry eye symptoms. Scores will range from 0 to 48, where 48 indicates severe dry eye.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 1 month

Population: Study terminated prior to data collection for outcomes. No data were collected for this outcome measure.

To evaluate the composition of the ocular surface microbiome using Shannon's diversity index. The alpha diversity (local species pool) of the population will be analyzed and compared pre-and post-treatment within and between the azithromycin and control groups. The difference between the bacterial microbiome in the azithromycin and placebo arm will be assessed using a PERMANOVA with an L2 norm distance measure. Secondary analyses will include L1 and L0 norms, as well as a phylogenetic distance. In addition, we will assess whether bacterial alpha diversity is decreased in the antibiotic treated arm with the primary outcome being the Simpson's index (L2), with secondary analyses assessing Shannon's (L1) and Richness (L0).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Study terminated prior to data collection for outcomes. No data were collected for this outcome measure.

To evaluate the composition of the ocular surface microbiome using Shannon's diversity index. The alpha diversity (local species pool) of the population will be analyzed and compared pre-and post-treatment within and between the azithromycin and control groups. The difference between the bacterial microbiome in the azithromycin and placebo arm will be assessed using a PERMANOVA with an L2 norm distance measure. Secondary analyses will include L1 and L0 norms, as well as a phylogenetic distance. In addition, we will assess whether bacterial alpha diversity is decreased in the antibiotic treated arm with the primary outcome being the Simpson's index (L2), with secondary analyses assessing Shannon's (L1) and Richness (L0).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 1 month

Population: Study terminated prior to data collection for outcomes. No data were collected for this outcome measure.

Dry eye questionnaire 5 - used to evaluate the degree of dry eye symptoms. Scores range from 0-22. A score of 0 represents the minimum dry eye symptoms someone may have and a score of 22 represents the maximum dry eye symptoms someone may have.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Study terminated prior to data collection for outcomes. No data were collected for this outcome measure.

Dry eye questionnaire 5 - used to evaluate the degree of dry eye symptoms. Scores range from 0-22. A score of 0 represents the minimum dry eye symptoms someone may have and a score of 22 represents the maximum dry eye symptoms someone may have.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 1 month.

Population: study terminated prior to any data analysis

Neuropathic pain inventory for the eye - used to study neuropathic vs stimulatory eye pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Study terminated prior to data collection for outcomes. No data were collected for this outcome measure.

Neuropathic pain inventory for the eye - used to study neuropathic vs stimulatory eye pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 1 month

Population: Study terminated prior to data collection for outcomes. No data were collected for this outcome measure.

Personal Health Questionnaire - a brief anxiety and depression questionnaire. Will be used in this study to evaluate the interaction between depression/anxiety and response to treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Study terminated prior to data collection for outcomes. No data were collected for this outcome measure.

Personal Health Questionnaire - a brief anxiety and depression questionnaire. Will be used in this study to evaluate the interaction between depression/anxiety and response to treatment.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Azithromycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie Schallhorn, MD

University of California San Francisco CA

Phone: 415-514-1922

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place