NCT02236403

Brief Summary

Blepharitis is a endemic inflammatory disease caused mainly by Demodex folliculorum and Demodex Brevis, This mites are often associated with anaerobic bacteria that produces a skin inflammation, so a intervention that reduces the number of mites and bacteria would be desirable. Ivermectin a macrolid compound have demonstrated activity against scabies and lice in humans and in animals and a single application have show a good response in lice eradication. In this study , investigators will determinate the security and effectiveness of this compound in the eradication of mites

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

September 8, 2014

Last Update Submit

May 3, 2021

Conditions

Chronic Blepharitis

Keywords

Blepharitis , Demodex, Ivermectin, Metronidazole

Outcome Measures

Primary Outcomes (1)

  • Erradication of Demodex mites

    Reduction in mites count after treatment compared to baseline data. If mites are not observed in the last visit a complete eradication will be considered. Patients with one or more mites will be considered as a incomplete eradication

    2 months

Secondary Outcomes (1)

  • Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score

    2 months

Study Arms (2)

Ivermectin 0.1% Metronidazole 1%

EXPERIMENTAL

30 patients will receive the treatment and at 15 days a second visit will be done and changes in mite counts will be determinated and correlated with symtoms and signs.

Drug: Ivermectin 0.1% Metronidazole 1%

Control

PLACEBO COMPARATOR

30 volunters with no signs of blepharitis and with eyelashes with no demodex .None intervention. Symptoms and signs will be compared with experimental group

Other: None intervention

Interventions

Ivermectin 0.1% Metronidazole 1%DRUG
Also known as: 22,23-dihydroavermectin B1a + 22,23-dihydroavermectin B1b
Ivermectin 0.1% Metronidazole 1%
None interventionOTHER

Volunteers with no signs of blepharitis and with eyelashes with no demodex. Symptoms and signs will be compared with experimental group

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic Demodex blepharitis for duration of at least 3 months.
  • Age range: 18 yeras and older.
  • Both genders and all ethnic groups comparable with the local community.
  • Able to understand and willing to sign a written informed consent
  • Able and willing to cooperate with the investigational plan.
  • Able and willing to complete all mandatory follow-up visits.

You may not qualify if:

  • Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.
  • Children under 18.
  • Pregnant women or expecting to be pregnant during the study.
  • Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
  • Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).
  • Concomitant use of systemic antibiotics or steroids.
  • Contact lens wear
  • Active ocular infection or allergy
  • Unable to close eyes or uncontrolled blinking Previous allergic reaction to metronidazole and / or ivermectin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Engativa

Bogotá, Colombia

Location

MeSH Terms

Conditions

Blepharitis

Interventions

Ivermectin22,23-dihydroavermectin B(1)aavermectin H2B1b

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2014

First Posted

September 10, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

May 6, 2021

Record last verified: 2021-05

Locations

CO(1)