Treatment Protocol for Recurrent Cases of Bacterial Posterior Blepharitis

JRCT ID: jRCT1071230068

Registered date:29/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: posterior blepharitis
• Date of first enrollment: 05/09/2023
• Target sample size: 50
• Study type: Observational

Outcome(s)

• Primary Outcome: Recovery rate at 14 days after the start of eye drops (judged by the attending physician)

Secondary Outcome

1) Distribution and susceptibility of bacteria detected at Initial examination
2) Eradication rate of bacteria detected at the time of the initial visit
3) Changes in bacteria detected and susceptibility at the time of the initial visit, 14 days after the start of eye drops, and 1 month after the end of eye drops
4) Changes in scores of subjective symptoms and objective findings (as judged by the attending physician)
5) Changes in scores of objective findings by assessors (assessor's judgment)
6) Correlation of OSDI scores based on patient questionnaireswith other findings and subjective symptoms
7) Recurrence rate (recurrence rate during the period from 14 days after the start of eye drops to 1 month after the end of eye drops)

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients 16 years of age or older with posterior blepharitis (with or without concurrent anterior blepharitis)
2) Patients with a history of bacterial posterior blepharitis in the same eye previously treated with 1% azithromycin ophthalmic solution
3) Patients with a total score of 4 or more of signs (eyelid redness eyelid margin redness, eyelash discharge, and conjunctival hyperemia) and symptoms (foreign body sensation, lacrimation) and a score of 1 or more of eyelid redness eyelid margin redness, and a score of 1 or more of symptoms.
4) Patients who are able to administer ophthalmoplegia appropriately.
5) Patients who understand the contents of the consent document and are able to give written consent
6) Patients who are able to come to the hospital on the day of observation as instructed by the investigator.

Exclude criteria

1) Patients presenting with anterior blepharitis only
2) Patients with eyelid diseases other than blepharitis (e.g., entropion, eyelid tumor)
3) Patients with bacterial, fungal, viral, allergic, or other inflammatory diseases of the external eye (e.g., conjunctivitis, keratitis) other than blepharitis
4) Patients with severe ocular surface disease
5) Patients who have received topical or systemic administration of antibacterial agents (except 1% azithromycin ophthalmic solution), steroids, or immunosuppressive agents within the past 2 weeks
6) Patients who have used 1% azithromycin ophthalmic solution within 3 weeks
7) Patients deemed inappropriate for inclusion in this study by the principal investigator (investigator, etc.)
8) Other patients who the principal investigator (investigator, etc.) determines to be inappropriate for the safe conduct of this study.

Related Information

• Primary Sponsor: Nejima Ryohei