Efficacy of IPL Treatment of Dry Eye and Ocular Rosacea

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03194698
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.6
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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: Intense Pulsed Light Treatment (IPL); Procedure: Meibomian Gland Expression	N/A

Study Design

• Study Type: Interventional
• 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: Aug 17, 2017
• Actual Primary Completion Date: Dec 6, 2018
• Actual Study Completion Date: Dec 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MGX and Intense Pulsed Light Treatment (IPL) Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX)	Device: Intense Pulsed Light Treatment (IPL); IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments.; Procedure: Meibomian Gland Expression; Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
Active Comparator: Meibomian Gland Expression (MGX) Treatment with 4 visits and 4 treatments of MGX only	Procedure: Meibomian Gland Expression; Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.

Outcome Measures

Primary Outcome Measures

1. Change in Ocular Surface Disease Index (OSDI) Symptom Survey Score [baseline, 3 months]

   Symptom survey on severity of dry eye symptoms. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.

Secondary Outcome Measures

1. Change in Meibomian Glands Open - Right Lower Lid [baseline, 3 months]

   The count of manual expression of the meibomian glands. A thumb is placed against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.

2. Change in Meibomian Glands Open - Left Lower Lid [3 months]

   The count of manual expression of the meibomian glands. A thumb is placed against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Joanne F Shen, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 28, 2017

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Joanne F. Shen, M.D., Chair, Department of Ophthalmology - Arizona, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03194698
• Other Study ID Numbers: 16-008492
• First Posted: Jun 21, 2017
• Last Update Posted: Jan 3, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Joanne F. Shen, M.D., Chair, Department of Ophthalmology - Arizona, Mayo Clinic: Intense Pulsed Light
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Rosacea

Study Results

Participant Flow

Arm/Group Title	MGX and Intense Pulsed Light Treatment (IPL)	Meibomian Gland Expression (MGX)
Arm/Group Description	Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX) Intense Pulsed Light Treatment (IPL): IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments. Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.	Treatment with 4 visits and 4 treatments of MGX only Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	MGX and Intense Pulsed Light Treatment (IPL)	Meibomian Gland Expression (MGX)	Total
Arm/Group Description	Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX) Intense Pulsed Light Treatment (IPL): IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments. Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.	Treatment with 4 visits and 4 treatments of MGX only Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.3 (11.7)	60.5 (12.1)	59.9 (11.6)
Sex: Female, Male (Count of Participants)
Female	7 70%	10 100%	17 85%
Male	3 30%	0 0%	3 15%
Race/Ethnicity, Customized (Count of Participants)
Hispanic/Latino	0 0%	1 10%	1 5%
Not Disclosed	1 10%	0 0%	1 5%
White	9 90%	9 90%	18 90%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Change in Ocular Surface Disease Index (OSDI) Symptom Survey Score
Description	Symptom survey on severity of dry eye symptoms. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.
Time Frame	baseline, 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MGX and Intense Pulsed Light Treatment (IPL)	Meibomian Gland Expression (MGX)
Arm/Group Description	Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX) Intense Pulsed Light Treatment (IPL): IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments. Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.	Treatment with 4 visits and 4 treatments of MGX only Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
Measure Participants	10	10
Mean (Standard Deviation) [percentage of change in OSDI score]	-25.9 (20.0)	-2.0 (17.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MGX and Intense Pulsed Light Treatment (IPL), Meibomian Gland Expression (MGX)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0312
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Change in Meibomian Glands Open - Right Lower Lid
Description	The count of manual expression of the meibomian glands. A thumb is placed against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
Time Frame	baseline, 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MGX and Intense Pulsed Light Treatment (IPL)	Meibomian Gland Expression (MGX)
Arm/Group Description	Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX) Intense Pulsed Light Treatment (IPL): IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments. Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.	Treatment with 4 visits and 4 treatments of MGX only Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
Measure Participants	10	10
Mean (Standard Deviation) [percentage of blocked meibomian pores]	6.9 (11.0)	5.0 (11.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MGX and Intense Pulsed Light Treatment (IPL), Meibomian Gland Expression (MGX)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.79
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Change in Meibomian Glands Open - Left Lower Lid
Description	The count of manual expression of the meibomian glands. A thumb is placed against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MGX and Intense Pulsed Light Treatment (IPL)	Meibomian Gland Expression (MGX)
Arm/Group Description	Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX) Intense Pulsed Light Treatment (IPL): IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments. Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.	Treatment with 4 visits and 4 treatments of MGX only Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
Measure Participants	10	10
Mean (Standard Deviation) [percentage of blocked meibomian]	14.4 (16.1)	10.0 (14.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MGX and Intense Pulsed Light Treatment (IPL), Meibomian Gland Expression (MGX)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.74
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	Adverse Events were collected over a period of 3 months
Arm/Group Title	MGX and Intense Pulsed Light Treatment (IPL)		Meibomian Gland Expression (MGX)
Arm/Group Description	Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX) Intense Pulsed Light Treatment (IPL): IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments. Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.		Treatment with 4 visits and 4 treatments of MGX only Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
All Cause Mortality
	MGX and Intense Pulsed Light Treatment (IPL)		Meibomian Gland Expression (MGX)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	MGX and Intense Pulsed Light Treatment (IPL)		Meibomian Gland Expression (MGX)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	MGX and Intense Pulsed Light Treatment (IPL)		Meibomian Gland Expression (MGX)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.