Last reviewed · How we verify

NCT04780165

Efficacy and Tolerability of Blephademodex Wipes

Completed NA Last updated 3 March 2021
What this trial tests

NA trial testing Blephademodex in Demodex Blepharitis in 50 participants. Completed in 14 May 2020.

Timeline
11 September 2019
Primary endpoint
13 March 2020
14 May 2020

Quick facts

Lead sponsorLaboratoires Thea
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment50
Start date11 September 2019
Primary completion13 March 2020
Estimated completion14 May 2020
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

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:

Other trials of Blephademodex

Trials testing the same drug.

Other Laboratoires Thea trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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