NCT02938078

Brief Summary

The primary study objectives are: to evaluate (1) the change in ocular discomfort at 30 days and (2) the change in signs and symptoms of ocular surface disease in demodex-positive subjects beginning the use of Avenova.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2018

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

1.9 years

First QC Date

October 14, 2016

Last Update Submit

August 17, 2020

Conditions

Blepharitis

Outcome Measures

Primary Outcomes (9)

  • Change in Severity of Markers of Inflammation

    Clinical parameters include prevalence of demodex mites.

    30 days

  • Change in Severity of Markers of Inflammation

    Clinical exam parameters include prevalence of tear film break up time.

    30 days

  • Change in Severity of Markers of Inflammation

    Clinical exam parameters include corneal and conjunctival staining.

    30 days

  • Change in Severity of Markers of Inflammation

    Clinical parameters include evaluation of meibomian gland including evaluation of lipid layer thickness..

    30 days

  • Change in Severity of Markers of Inflammation using tear osmolarity.

    Clinical parameters include tear osmolarity.

    30 days

  • Change in Severity of Markers of Inflammation

    Clinical parameters include tear ferning patterns.

    30 days

  • Change in Severity of Markers of Inflammation

    Clinical parameters include meibomian gland evaluation

    30 days

  • Change in Ocular Discomfort

    Change in ocular discomfort based on scores from Eyelid Inflammation questionnaire.

    30 days

  • Change in Ocular Discomfort

    Change in ocular discomfort based on scores from Ocular Surface Disease Index questionnaire. Scored on a scale of 0-100, with higher scores indicating greater disability.

    30 days

Study Arms (2)

Treatment Eye

EXPERIMENTAL

One eye will be treated with Avenova; the other eye will not be treated. The investigator is masked as to which eye is receiving Avenova product.

Device: Avenova Lid Cleanser

Non-Treatment Eye

NO INTERVENTION

One eye will be treated with Avenova; the other eye will not will be treated. The investigator is masked as to which eye is receiving Avenova product.

Interventions

Avenova Lid CleanserDEVICE

Avenova lid cleanser is an FDA-cleared saline solution preserved with 0.01% pure hypochlorous acid.

Treatment Eye

Eligibility Criteria

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

You may qualify if:

  • Subject signed and dated a IRB-approved informed consent document
  • Mild or greater Demodex (minimum 15 observable mites in six lashes)
  • Score of 20 or more on the OSDI Questionnaire
  • Score of 20 or more on the Eyelid Inflammation Questionnaire

You may not qualify if:

  • Currently enrolled in another prospective research study
  • Unable to attend two follow-up visits over 30 days
  • Current allergic conjunctivitis of the cornea, conjunctiva, or eyelid in either eye
  • Prior ocular trauma where surgery was indicated
  • Prior corneal transplant in either eye
  • Any ocular surgery within the past six months
  • Abnormal corneal scarring, erosions, or Stevens-Johnson syndrome
  • Anticipation of ocular surgery within the next 30 days
  • Non-English speaking
  • Pregnant, nursing, or expect to become pregnant within the next 30 days
  • Known sensitivity to chlorine or Avenova
  • Moderate, or severe conjunctivochalasis
  • Contact lenses within the last 30 days and unwilling to discontinue for 30 days
  • Use of topical cyclosporine for less than 6 continuous months prior to baseline
  • Procedure such as pulsed light or commercial lid massage in last 30 days
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minnesota eye Consultants, PA

Bloomington, Minnesota, 55431, United States

Location

MeSH Terms

Conditions

Blepharitis

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Officials

  • Ahmad M Fahmy, OD

    Minnesota Eye Consultants

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 19, 2016

Study Start

October 1, 2016

Primary Completion

August 24, 2018

Study Completion

August 24, 2018

Last Updated

August 20, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)