Last reviewed · How we verify
NCT04780165
Efficacy and Tolerability of Blephademodex Wipes
NA trial testing Blephademodex in Demodex Blepharitis in 50 participants. Completed in 14 May 2020.
13 March 2020
Quick facts
| Lead sponsor | Laboratoires Thea |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 11 September 2019 |
| Primary completion | 13 March 2020 |
| Estimated completion | 14 May 2020 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Blephademodex
Conditions studied
- Demodex Blepharitis — all drugs for Demodex Blepharitis →
Sponsor
Laboratoires Thea — full company profile →
Who can join
Eligibility, any sex, with Demodex Blepharitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary Objective \- To evaluate efficacy of Blephademodex eyelid hygiene wipe treatment with a subsequent maintenance period with Blephaclean lid cleansing wipes in Demodex blepharitis, as assessed by the change in ocular symptoms by a Global Discomfort Scale (GDS). Secondary Objectives * To evaluate the efficacy of Blephademodex eyelid hygiene wipe treatment in Demodex blepharitis as assessed by the change alone and in combination with a subsequent maintenance period of treatment with Blephaclean eyelid cleansing wipes ocular symptoms by: adapted TOSS; SANDE; specific blepharitis symptoms; Demodex count; ocular surface redness (Efron scale); lid margin redness/swelling (Efron / custom scale); Dandruff coverage at bases of eyelashes; ocular surface staining (Oxford scale; corneal only) * To evaluate subject and physician satisfaction with Blephademodex eyelid hygiene wipes * To evaluate ease of use for Blephademodex eyelid hygiene wipes * Adverse events are documented and analyzed.
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 NCT04780165
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Blephademodex
Trials testing the same drug.
- NCT03987230 — Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum · NA · completed
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 NCT04780165 (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 March 2021
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/NCT04780165.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing