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Trial Outcomes & Findings for Efficacy of IPL Treatment of Dry Eye and Ocular Rosacea (NCT NCT03194698)

NCT ID: NCT03194698

Last Updated: 2020-01-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

baseline, 3 months

Results posted on

2020-01-03

Participant Flow

Participant milestones

Participant milestones
Measure
MGX and Intense Pulsed Light Treatment (IPL)
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.
Meibomian Gland Expression (MGX)
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.
Overall Study
STARTED
10
10
Overall Study
COMPLETED
10
10
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of IPL Treatment of Dry Eye and Ocular Rosacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
MGX and Intense Pulsed Light Treatment (IPL)
n=10 Participants
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.
Meibomian Gland Expression (MGX)
n=10 Participants
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
n=20 Participants
Total of all reporting groups
Age, Continuous
59.3 years
STANDARD_DEVIATION 11.7 • n=5 Participants
60.5 years
STANDARD_DEVIATION 12.1 • n=7 Participants
59.9 years
STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
10 Participants
n=7 Participants
17 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
0 Participants
n=7 Participants
3 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic/Latino
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Not Disclosed
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
White
9 Participants
n=5 Participants
9 Participants
n=7 Participants
18 Participants
n=5 Participants
Region of Enrollment
United States
10 participants
n=5 Participants
10 participants
n=7 Participants
20 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
MGX and Intense Pulsed Light Treatment (IPL)
n=10 Participants
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.
Meibomian Gland Expression (MGX)
n=10 Participants
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.
Change in Ocular Surface Disease Index (OSDI) Symptom Survey Score
-25.9 percentage of change in OSDI score
Standard Deviation 20.0
-2.0 percentage of change in OSDI score
Standard Deviation 17.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
MGX and Intense Pulsed Light Treatment (IPL)
n=10 Participants
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.
Meibomian Gland Expression (MGX)
n=10 Participants
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.
Change in Meibomian Glands Open - Right Lower Lid
6.9 percentage of blocked meibomian pores
Standard Deviation 11.0
5.0 percentage of blocked meibomian pores
Standard Deviation 11.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
MGX and Intense Pulsed Light Treatment (IPL)
n=10 Participants
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.
Meibomian Gland Expression (MGX)
n=10 Participants
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.
Change in Meibomian Glands Open - Left Lower Lid
14.4 percentage of blocked meibomian
Standard Deviation 16.1
10.0 percentage of blocked meibomian
Standard Deviation 14.1

Adverse Events

MGX and Intense Pulsed Light Treatment (IPL)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Meibomian Gland Expression (MGX)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joanne F. Shen, M.D.

Mayo Clinic

Phone: 480-301-8085

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place