The Efficacy of Permethrin 5%, Fusidic Acid 1% and Synthomycine 5% for Demodex - Blepharitis

Phase 4

• Conditions: Inflammation of the Eyelids
• Interventions: Drug: Synthomycine 5%; Drug: Fusidic Acid 1% M/R Eye Drops; Drug: Permethrin 5%

• Registration Number: NCT03105505
• Lead Sponsor: Barzilai Medical Center

Brief Summary

The study aims to investigate the effect of Permethrin 5% treatment on Signs and symptoms of Demodex-blepharitis in comparison to Synthomycine 5% and Fucithalmic (fusidic acid 1%) .

Detailed Description

3 arms study. 75 patient total, 25 patients in each group.

Group A (study group) patients will apply facially Permethrin 5% every night for 3 months.

Group B patients will apply on the eyelids Fusidic acid 1% every night for 3 months.

Group C patients will apply on the eyelids Synthomycine 5% every night for 3 months

Follow up Evaluation will be made after one week, one month, two months, three months, 4 months and half a year.

Study Timeline

• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-10
• Study Start: 2017-04-28
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-30
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Adult (Age ≥18Y) individuals clinically diagnosed with Demodex- blepharitis.

Exclusion Criteria

• Known sensitivity to all study medications or components. Pregnant women and individuals deemed unfit to provide informed consent. Systemic steroid use.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synthomycine 5%,	Synthomycine 5%	Contains chloramphenicol 5%.
Fusidic Acid 1%	Fusidic Acid 1% M/R Eye Drops	Contains 1% w/w fusidic acid anhydrous (as the hemihydrates) and 0.011% w/w.
Permethrin 5%	Permethrin 5%	Contains permethrin 5% w/w (equivalent to 50 mg/g), formaldehyde solution 0.278% w/w and butylated hydroxytoluene (E321) 0.02% w/w.

Primary Outcome Measures

Name	Time	Method
Improvement in symptoms and complaints in group A.	2 months	OSDI Questionnaires that describe the severity of the ocular surface disease condition are filled in each visit.
Decrease in demodex infestation in group A (permethrin 5%).	2 months	significant decrease in demodex infestation in comparison to group B and C.

Trial Locations

Locations (1)

Barzilai Medical Center; 🇮🇱 Ashqelon, Israel