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NCT01089608
Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis (Pilot Phase II Clinical Study, Multicentre, Randomised, Double Masked, Comparative, 2 X 40 Patients)
Phase 2 trial testing Azithromycin in Blepharitis in 93 participants. Completed in 1 June 2012.
1 June 2012
Quick facts
| Lead sponsor | Laboratoires Thea |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 93 |
| Start date | 1 March 2010 |
| Primary completion | 1 June 2012 |
| Estimated completion | 1 June 2012 |
| Sites | 1 location across France |
Drugs / interventions tested
- Azithromycin (azithromycin) — full drug profile →
- Povidone (CROSPOVIDONE) — full drug profile →
Conditions studied
- Blepharitis — all drugs for Blepharitis →
Sponsor
Laboratoires Thea — full company profile →
Who can join
18 and older, any sex, with Blepharitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Visual Analogue Scale (VAS - Ranges 0-100 mm)
Time frame: 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)
Sponsor's own description
The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01089608
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Blepharitis
Currently open trials in the same condition.
- NCT06371300 — Photobiomodulation With REd vs BluE Light (REBEL) · NA · recruiting
- NCT06054217 — Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex · Phase 2 · active not recruiting
- NCT04603222 — Evaluation of SUMMIT BRUSH in Treatment of Blepharitis · NA · recruiting
Other Laboratoires Thea trials
Trials by the same sponsor.
- NCT07169695 — A Study to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants With Moderate to Severe Vern · Phase 2 · recruiting
- NCT07234318 — A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyc · active not recruiting
- NCT07234292 — Evaluation of Patient Satisfaction With Blephaderm as a Complementary Care in Post-eyelid Surgery. · not yet recruiting
- NCT07007702 — Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Dise · completed
- NCT06375499 — Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome. · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01089608 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Laboratoires Thea
- Last refreshed: 3 November 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01089608.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing