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NCT00803452 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by University of Louisville.

Completed
Registry status
Phase 4
Development phase
31
Enrollment target

NCT00803452: Completed Phase 4 study, sponsored by University of Louisville.

NCT00803452 is a Phase 4 study that has completed, run by University of Louisville. The registered enrollment target is 31 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00803452, a Phase 4 study, has completed, sponsored by University of Louisville.

COMPLETED
Registry status
Phase 4
Development phase
31 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG azithromycin
  • DRUG doxycycline

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2008-07
Est. Completion 2010-12
Phase Phase 4
University of Louisville

217 total trials

What the finished NCT00803452 record still lists

NCT00803452 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which azithromycin is the first listed.

NCT00803452 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00803452 about?

NCT00803452 is a clinical study titled "Lipids of the Human Tear Film and Their Effect on Tear Stability". 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.

What is the current status of trial NCT00803452?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2008-07. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00803452?

The interventions under investigation include: azithromycin (DRUG), doxycycline (DRUG).

Who is sponsoring clinical trial NCT00803452?

This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00803452's enrollment target sits among peer trials

31 1544th of 2000 higher than 449 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00803452, the US trial registry maintained by the National Library of Medicine. NCT00803452 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.