NCT05608980

Brief Summary

This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

October 27, 2022

Last Update Submit

November 4, 2022

Conditions

Blepharitis

Keywords

BlepharitisHypochlorous AcidEyelid cleanserEyelid hygieneMeibomian gland dysfunction

Outcome Measures

Primary Outcomes (4)

  • OSDI

    0-100 score based on the ocular surface disease index (OSDI) questionnaire

    Change from baseline OSDI at 2 weeks

  • meibum quality

    Meibum quality were measured by using firm digital pressure applied over 5 lower lid glands. Meibum quality was graded as: grade 0, clear; grade 1, cloudy; grade 2, cloudy with granular debris; and grade 3, thick like toothpaste.

    Change from baseline meibum quality score at 2 weeks

  • Corneal fluorescein staining

    scored by Oxford staining score

    Change from baseline corneal fluorescein staining at 2 weeks

  • FBUT

    fluorescent tear break up time fluorescein tear film break-up time

    Change from baseline FTBUT at 2 weeks

Study Arms (2)

Treatment arm

ACTIVE COMPARATOR

0.01%hypochlorous acid group

Drug: 0.01% hypochlorous acid

Placebo

PLACEBO COMPARATOR

eyelid wipes

Drug: Placebo

Interventions

0.01% hypochlorous acidDRUG

once daily 0.01% hypochlorous acid topical treatment via ultrasonic atomization for 2 weeks

Also known as: 0.01%HOCI
Treatment arm
PlaceboDRUG

once daily eyelid wipes for 2 weeks

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older.
  • Anterior or mixed (anterior + posterior) blepharitis.
  • Similar clinical condition of both eyes.
  • A negative urine pregnancy test result for women of childbearing potential
  • Normal lid position and closure
  • Ability to understand and provide informed consent to participate in this study
  • Willingness to follow study instructions and likely to complete all required visits.

You may not qualify if:

  • Any ocular surface disease other than blepharitis.
  • Known allergy to hypochlorous acid or boric acid.
  • Eye surgery in the last 6 months.
  • History of Stevens-Johnson syndrome or ocular pemphigoid
  • Ocular trauma in the last 6 months.
  • Use of contact lenses in the last 6 months.
  • Pregnancy or lactation.
  • Daily use of makeup on lashes.
  • Any ocular or systemic medication that might affect the ocular microbiota (antibiotics, immunosuppressants, steroids).
  • Pregnant or lactating women
  • Signs of current infection, including fever and current treatment with antibiotics
  • Liver, renal, or hematologic disease
  • The use of any other investigational drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

BlepharitisMeibomian Gland Dysfunction

Interventions

Hypochlorous Acid

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Acids, NoncarboxylicAcidsInorganic ChemicalsChlorine CompoundsReactive Oxygen SpeciesFree RadicalsOxidesOxygen Compounds

Study Officials

  • Jiaxu Hong

    Eye & ENT Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaxu Hong

CONTACT

13917440201jiaxu_hong@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, controlled, randomized study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2022

First Posted

November 8, 2022

Study Start

July 1, 2022

Primary Completion

December 1, 2022

Study Completion

May 1, 2023

Last Updated

November 8, 2022

Record last verified: 2022-11

Locations

CN(1)