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Ocular Comfort and Inflammation in Lid Hygiene Therapy

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ClinicalTrials.gov Identifier: NCT02938078
Recruitment Status : Unknown
Verified October 2016 by Minnesota Eye Consultants, P.A..
Recruitment status was:  Recruiting
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Collaborator:
NovaBay Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Minnesota Eye Consultants, P.A.

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.

Condition or disease Intervention/treatment Phase
Blepharitis Device: Avenova Lid Cleanser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Ocular Comfort and Markers of Inflammation in Subjects Undergoing Lid Hygiene Therapy
Study Start Date : October 2016
Estimated Primary Completion Date : May 2017

Arm Intervention/treatment
Experimental: Treatment Eye
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
Avenova lid cleanser is an FDA-cleared saline solution preserved with 0.01% pure hypochlorous acid.

No Intervention: Non-Treatment Eye
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.



Primary Outcome Measures :
  1. Reduction in Severity of Markers of Inflammation [ Time Frame: 30 days ]
  2. Change in Ocular Discomfort [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Known history of autoimmune disease
  • Punctal plugs placed within the last 30 days
  • Use of Avenova or other lid cleansers within the last 30 days
  • Changes in systemic or ocular medications in the last 30 days
  • Unwilling to commit to the same ocular and systemic medications for 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938078


Contacts
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Contact: Erich J Berg, BA 952-567-6111 ejberg@mneye.com

Locations
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United States, Minnesota
Minnesota eye Consultants, PA Recruiting
Bloomington, Minnesota, United States, 55431
Contact: Erich J Berg, Ba    952-567-6111    ejberg@mneye.com   
Principal Investigator: Ahmad M. Fahmy, OD         
Sponsors and Collaborators
Minnesota Eye Consultants, P.A.
NovaBay Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Ahmad M Fahmy, OD Minnesota Eye Consultants

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Responsible Party: Minnesota Eye Consultants, P.A.
ClinicalTrials.gov Identifier: NCT02938078     History of Changes
Other Study ID Numbers: MEC-NBY-2016
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Blepharitis
Inflammation
Pathologic Processes
Eyelid Diseases
Eye Diseases