Trial Outcomes & Findings for Lipids of the Human Tear Film and Their Effect on Tear Stability (NCT NCT00803452)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

31 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Doxycycline Oral doxycycline doxycycline: Oral doxycycline 100mg bid	Azithromycin Topical azithromycin daily to the conjunctival culdesac azithromycin: topical 1% azithromycin daily to eye
Overall Study STARTED	9	22
Overall Study COMPLETED	9	17
Overall Study NOT COMPLETED	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Doxycycline Oral doxycycline doxycycline: Oral doxycycline 100mg bid	Azithromycin Topical azithromycin daily to the conjunctival culdesac azithromycin: topical 1% azithromycin daily to eye
Overall Study Adverse Event	0	2
Overall Study Lost to Follow-up	0	3

Baseline Characteristics

Lipids of the Human Tear Film and Their Effect on Tear Stability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doxycycline n=9 Participants Oral doxycycline doxycycline: Oral doxycycline 100mg bid	Azithromycin n=22 Participants Topical azithromycin daily to the conjunctival culdesac azithromycin: topical 1% azithromycin daily to eye	Total n=31 Participants Total of all reporting groups
Age, Continuous	68 years STANDARD_DEVIATION 4 • n=5 Participants	64 years STANDARD_DEVIATION 3 • n=7 Participants	65 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	22 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Doxycycline n=18 eyes Oral doxycycline doxycycline: Oral doxycycline 100mg bid	Azithromycin n=44 eyes Topical azithromycin daily to the conjunctival culdesac azithromycin: topical 1% azithromycin daily to eye
Global Response to Therapy	16 eyes	41 eyes

Adverse Events

Doxycycline

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

Professor Douglas Borchman

University of Louisville

Phone: 502 852 7435

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place