Trial Outcomes & Findings for Intense Pulsed Light Study for Dry Eye Disease (NCT NCT03089580)
NCT ID: NCT03089580
Last Updated: 2019-10-08
Results Overview
Three tear breakup time measurements will be taken of each eye. The averages of those eyes treated with intense pulsed light treatment will be compared to those eyes that received the sham treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
16.5 weeks
Results posted on
2019-10-08
Participant Flow
14 participants were recruited. Each participant received the Intense Pulse Light treatment in one eye and the sham treatment in their other eye.
Unit of analysis: Eyes
Participant milestones
| Measure |
Intense Pulsed Light Treatment
Participants had one eye randomized to receive the intense pulsed light (IPL) therapy treatment in the right or left eye, while their other eye received the sham treatment. 14 eyes received IPL, and 14 eyes received the sham treatment. Throughout the study, the IPL treatment eye was always the same for each individual.
Participants received approximately 15 light spots to areas around the eye, lower eyelid, cheek, side of the nose and temple. The energy level was based on skin type. IPL was administered 4 times throughout the study.
Intense Pulsed Light Therapy: Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants received a total of 4 treatments over the course of the study.
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|---|---|
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Overall Study
STARTED
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14 28
|
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Overall Study
COMPLETED
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12 24
|
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Overall Study
NOT COMPLETED
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2 4
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Reasons for withdrawal
| Measure |
Intense Pulsed Light Treatment
Participants had one eye randomized to receive the intense pulsed light (IPL) therapy treatment in the right or left eye, while their other eye received the sham treatment. 14 eyes received IPL, and 14 eyes received the sham treatment. Throughout the study, the IPL treatment eye was always the same for each individual.
Participants received approximately 15 light spots to areas around the eye, lower eyelid, cheek, side of the nose and temple. The energy level was based on skin type. IPL was administered 4 times throughout the study.
Intense Pulsed Light Therapy: Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants received a total of 4 treatments over the course of the study.
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|---|---|
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Overall Study
Lost to Follow-up
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2
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Baseline Characteristics
Intense Pulsed Light Study for Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Intense Pulsed Light Treatment
n=14 Participants
Participants had one eye randomized to receive the intense pulsed light (IPL) therapy treatment in the right or left eye, while their other eye received the sham treatment. 14 eyes received IPL, and 14 eyes received the sham treatment. Throughout the study, the IPL treatment eye was always the same for each individual.
Participants received approximately 15 light spots to areas around the eye, lower eyelid, cheek, side of the nose and temple. The energy level was based on skin type. IPL was administered 4 times throughout the study.
Intense Pulsed Light Therapy: Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants received a total of 4 treatments over the course of the study.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 16.5 weeksThree tear breakup time measurements will be taken of each eye. The averages of those eyes treated with intense pulsed light treatment will be compared to those eyes that received the sham treatment.
Outcome measures
| Measure |
Intense Pulsed Light Treatment
n=14 Participants
Participants had one eye randomized to receive the intense pulsed light (IPL) therapy treatment in the right or left eye, while their other eye received the sham treatment. 14 eyes received IPL, and 14 eyes received the sham treatment. Throughout the study, the IPL treatment eye was always the same for each individual.
Participants received approximately 15 light spots to areas around the eye, lower eyelid, cheek, side of the nose and temple. The energy level was based on skin type. IPL was administered 4 times throughout the study.
Intense Pulsed Light Therapy: Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants received a total of 4 treatments over the course of the study.
|
Sham Treatment
n=14 Participants
Participants had one eye randomized to receive the intense pulsed light (IPL) therapy treatment in the right or left eye, while their other eye received the sham treatment. 14 eyes received IPL, and 14 eyes received the sham treatment. Throughout the study, the IPL treatment eye was always the same for each individual.
Participants received approximately 15 light spots to areas around the eye, lower eyelid, cheek, side of the nose and temple. The energy level was based on skin type. IPL was administered 4 times throughout the study.
Intense Pulsed Light Therapy: Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants received a total of 4 treatments over the course of the study.
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|---|---|---|
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Tear Breakup Time Average
Visit 1 at Baseline
|
3.3 Seconds
Standard Deviation 1.3
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3.0 Seconds
Standard Deviation 1.5
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Tear Breakup Time Average
Visit 5 at 16.5 Weeks
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4.1 Seconds
Standard Deviation 2.3
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4.5 Seconds
Standard Deviation 2.5
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PRIMARY outcome
Timeframe: 7 MonthsPatients completed the Ocular Surface Disease Index Questionnaire at each visit before they received the IPL and sham treatments. The questionnaire is assessed on a scale of 0 to 100 with 0 meaning normal and the higher scores representing greater dry eye disease severity. This questionnaire has been validated to assess ocular symptoms for a patient but cannot be separated by eye. Therefore, the results cannot be given by treatment vs. sham, but for the participant overall.
Outcome measures
| Measure |
Intense Pulsed Light Treatment
n=14 Participants
Participants had one eye randomized to receive the intense pulsed light (IPL) therapy treatment in the right or left eye, while their other eye received the sham treatment. 14 eyes received IPL, and 14 eyes received the sham treatment. Throughout the study, the IPL treatment eye was always the same for each individual.
Participants received approximately 15 light spots to areas around the eye, lower eyelid, cheek, side of the nose and temple. The energy level was based on skin type. IPL was administered 4 times throughout the study.
Intense Pulsed Light Therapy: Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants received a total of 4 treatments over the course of the study.
|
Sham Treatment
Participants had one eye randomized to receive the intense pulsed light (IPL) therapy treatment in the right or left eye, while their other eye received the sham treatment. 14 eyes received IPL, and 14 eyes received the sham treatment. Throughout the study, the IPL treatment eye was always the same for each individual.
Participants received approximately 15 light spots to areas around the eye, lower eyelid, cheek, side of the nose and temple. The energy level was based on skin type. IPL was administered 4 times throughout the study.
Intense Pulsed Light Therapy: Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants received a total of 4 treatments over the course of the study.
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|---|---|---|
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Change in Scores of the Ocular Surface Disease Index Questionnaire
Visit 1 at Baseline
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29.7 score on a scale
Standard Deviation 21.6
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—
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Change in Scores of the Ocular Surface Disease Index Questionnaire
Visit 2 at 4 weeks
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25.6 score on a scale
Standard Deviation 17.2
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—
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Change in Scores of the Ocular Surface Disease Index Questionnaire
Visit 3 at 8 weeks
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23.6 score on a scale
Standard Deviation 20.1
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—
|
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Change in Scores of the Ocular Surface Disease Index Questionnaire
Visit 4 at 12 weeks
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20.7 score on a scale
Standard Deviation 18.6
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—
|
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Change in Scores of the Ocular Surface Disease Index Questionnaire
Visit 5 at 16.5 weeks
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23.7 score on a scale
Standard Deviation 19.8
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—
|
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Change in Scores of the Ocular Surface Disease Index Questionnaire
7 month phone call
|
22.2 score on a scale
Standard Deviation 19.5
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—
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Adverse Events
Intense Pulsed Light Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intense Pulsed Light Treatment
n=14 participants at risk
Participants will have one eye randomized to receive the intense pulsed light (IPL) therapy treatment and will receive the sham treatment in their other eye.
Participants will receive approximately 15 light spots to areas around the eye, lower eyelid, cheek, side of the nose and temple. The energy level will be based on skin type. IPL will be administered 4 times throughout the study.
Intense Pulsed Light Therapy: Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants will receive a total of 4 treatments over the course of the study.
|
Sham Treatment
n=14 participants at risk
Participants will have the other eye randomized to receive a sham treatment. The sham treatment will be conducted by placing the intense pulsed light (IPL) device to approximately 15 areas around the eye, lower eyelid, cheek, side of nose and temple without delivery of the light. The sham treatment will mimic the IPL treatment but no light will be delivered. Sham treatment will be administered 4 times throughout the study.
Sham Treatment: The sham treatment will mimic the IPL treatment but no light will be delivered. Sham treatment will be administered 4 times throughout the study.
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|---|---|---|
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Eye disorders
Subconjunctival Hemorrhage
|
0.00%
0/14 • 7 months
Adverse events for either eye were determined by the investigator as "possibly", "probably" or "definitely" related to the IPL treatment or study procedures
|
7.1%
1/14 • Number of events 1 • 7 months
Adverse events for either eye were determined by the investigator as "possibly", "probably" or "definitely" related to the IPL treatment or study procedures
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place