Trial · NCT01089608
Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis
NCT01089608, Phase 2, Completed, Laboratoires Thea; results first posted 2014-11-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis. Trials, record NCT01089608. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01089608
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis
- NCT number
- NCT01089608
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 93 participants, actual
- Lead sponsor
- Laboratoires Thea
- Conditions
- Blepharitis
- Interventions
- Azithromycin, Povidone
- First posted
- 2010-03-18
- Last updated
- 2014-11-04
- Other registries' IDs
- eudract:2009-017388-41
- Results first posted
- 2014-11-04
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Analogue Scale (VAS - Ranges 0-100 mm) | Baseline and D63 (D63 minus baseline) | The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome) |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Visual Analogue Scale (VAS - Ranges 0-100 mm) | Baseline and D63 (D63 minus baseline) | Modified ITT set: all randomised patients with at least one eligible treated eye, for whom any follow-up efficacy data are available. | units on a scale (from 0 to 100 mm) | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Visual Analogue Scale (VAS - Ranges 0-100 mm) | Unifluid | 36.5 | 95% Confidence Interval 30.5 to 42.4 | units on a scale (from 0 to 100 mm) | |
| Visual Analogue Scale (VAS - Ranges 0-100 mm) | Azithromycin | 28.5 | 95% Confidence Interval 22.7 to 34.3 | units on a scale (from 0 to 100 mm) |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Unifluid | 43 | |
| Overall Study | STARTED | Azithromycin | 50 | |
| Overall Study | COMPLETED | Unifluid | 43 | |
| Overall Study | COMPLETED | Azithromycin | 44 | |
| Overall Study | NOT COMPLETED | Unifluid | 0 | |
| Overall Study | NOT COMPLETED | Azithromycin | 6 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Unifluid | ||
| Total, all-cause mortality | Azithromycin | ||
| Total, other adverse events | Unifluid | 0 | 43 |
| Total, other adverse events | Azithromycin | 0 | 50 |
| Total, serious adverse events | Unifluid | 0 | 43 |
| Total, serious adverse events | Azithromycin | 0 | 50 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Unifluid vs Azithromycin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01089608
GET https://conductscience.org/api/trials/v1/NCT01089608/registered