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Efficacy of IPL Treatment of Dry Eye and Ocular Rosacea

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ClinicalTrials.gov Identifier: NCT03194698
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Joanne F. Shen, M.D., Mayo Clinic

Brief Summary:

Dry eye disease (DED) is a common condition that causes ocular discomfort and reduces visual acuity. The two categories of DED are evaporative dry eye and aqueous deficient dry eye. Both conditions can involve pathology of the meibomian glands, lacrimal glands, lids, tear film and surface cells. Meibomian gland dysfunction (MGD) is the leading cause of evaporative dry eye and contributes to aqueous deficient dry eye. The goal of MGD therapy is to provide long term improvement of symptoms for patients by improving the quality of meibum, increasing meibum flow, improving tear film stability and decreasing inflammation.

Commonly used therapies include preservative free drops, omega-3 fatty acid supplementation, topical cyclosporine, serum tears, topical azithromycin, oral doxycycline, moisture chambers, intraductal probing, lib margin exfoliation, automated thermal pulsation, warm compresses, among other. Despite this variety of symptoms, patients often do not experience complete or long term relief of symptoms.

Forced meibomian gland expression (MGX) has been shown to be an effective method of rehabilitating meibomian glands and improving dry eye symptoms. The eyelid margins are forcefully compressed to express gland contents. Research has shown improvement in patient symptoms with the use of MGX.

Intense pulsed light (IPL) have been used in dermatology to treat various conditions. Patients with DED who have tried other therapies and found no relief, often resort to IPL as a last resort. Research has shown IPL alone may be effective in improving patient symptoms. In addition, such studies have failed to show significant adverse events with the use of IPL.

Here, we propose a prospective, randomized, case controlled clinical pilot study to examine the efficacy for both subjective and objective measures. 20 patients with DED will be recruited and will be randomly assigned to one of two groups: MGX alone or MGX with IPL. Objective measures will include tear cytokine levels, impression cytology, meibography, tear osmolarity and others. Subjective measures will include quality of life screening tools.

We hypothesize that the use of MGX with IPL will lead to greater improvement in subjective dry eye symptoms and objective measures. Given the lack of adverse effects reported in the literature, we do not anticipate adverse effects in our study.

Rochester staff Drs. Faustch and Bourne are providing clinical research advice but have no contact with subjects or biospecimens.


Condition or disease Intervention/treatment Phase
Ocular Rosacea Dry Eye Device: IPL Procedure: MGX Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Examine Efficacy and Cytokines Levels After Meibomian Gland Expression (MGX) With and Without Intense Pulsed Light Treatment (IPL)
Actual Study Start Date : August 17, 2017
Actual Primary Completion Date : December 6, 2018
Actual Study Completion Date : December 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Treatment
Treatment with 4 visits and 4 treatments of IPL and MGX
Device: IPL
Intense Pulsed Light with Meibomian Gland Expression

Procedure: MGX
Meibomian Gland Expression

Active Comparator: Control
Treatment with 4 visits and 4 treatments of MGX only
Procedure: MGX
Meibomian Gland Expression




Primary Outcome Measures :
  1. Ocular Surface Disease Index symptom survey [ Time Frame: 4 months ]
    symptom survey on severity of dry eye symptoms


Secondary Outcome Measures :
  1. Pathologic microbial load [ Time Frame: 4 months ]
    Analysis of RNA of ocular microbiome in tear sample

  2. TGF-B1 growth cytokine level [ Time Frame: 4 month ]
    Analysis of growth cytokines in tear sample



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Dry eye of moderate severity with ocular rosacea diagnosed by ophthalmologist. No contraindications of severe ocular surface disease or inability to be safely treated with IPL.

Dry eye symptoms must be alleviated with topical anesthetic. No GVHD, Stevens Johnson, active allergic conjunctivitis or other conjunctivitis, alkali burn history.

Subjects must have at least 50% meibomian glands viable on meibography and no new treatments for dry eye in the past 6 months.

Contact lenses and refractive surgery is okay.


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): NCT03194698


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Joanne F Shen Mayo Clinic

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Responsible Party: Joanne F. Shen, M.D., Chair, Department of Ophthalmology - Arizona, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03194698     History of Changes
Other Study ID Numbers: 16-008492
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Joanne F. Shen, M.D., Mayo Clinic:
Intense Pulsed Light
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Rosacea
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Skin Diseases