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| Name | Class |
|---|---|
| Eversight Michigan/Michigan Eye Bank | UNKNOWN |
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This study will evaluate the efficacy of intense pulsed light (IPL) therapy for the treatment of dry eye disease. One eye of the participant will be randomized to receive the IPL treatment.
Dry eye disease (DED) affects tears and the front surface of the eye. Patients who have DED can experience symptoms of discomfort, blurry vision, redness, and pain. DED can also cause tears to become unstable which could result in damage to the front surface of the eye.
There are two types of DED. The one the investigators are studying is called evaporative dry eye disease. This type of DED occurs because the pores on the eyelids are not functioning properly. In preliminary studies, a new treatment called Intense Pulsed Light (IPL) has shown promise to reduce signs and symptoms of evaporative DED. IPL is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. It is commonly used for treatment of facial rosacea, acne, and hair, wrinkle and lesion removal. It is not currently approved for the treatment of dry eye disease. This treatment is thought to provide relief of evaporative DED symptoms and improve the expression of the pores on the edge of the eyelid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intense Pulsed Light Treatment | Experimental | Participants will have one eye randomized to receive the intense pulsed light (IPL) therapy treatment while their other eye will receive the sham treatment. 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. |
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| Sham Treatment | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intense Pulsed Light Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Breakup Time Average | 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. | 16.5 weeks |
| Change in Scores of the Ocular Surface Disease Index Questionnaire | Patients 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. | 7 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Wood, OD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
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14 participants were recruited. Each participant received the Intense Pulse Light treatment in one eye and the sham treatment in their other eye.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tear Breakup Time Average | 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. | Posted | Mean | Standard Deviation | Seconds | 16.5 weeks |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intense Pulsed Light Treatment | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subconjunctival Hemorrhage | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Wood | University of Michigan / Kellogg Eye Center | 734-615-2479 | skwood@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2019 | Sep 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D062325 | Intense Pulsed Light Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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| Sham Treatment | Procedure | 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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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | 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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| Primary | Change in Scores of the Ocular Surface Disease Index Questionnaire | Patients 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. | Posted | Mean | Standard Deviation | score on a scale | 7 Months |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Sham Treatment | 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. | 0 | 14 | 0 | 14 | 1 | 14 |
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| Title | Measurements |
|---|---|
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| Visit 4 at 12 weeks |
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| Visit 5 at 16.5 weeks |
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| 7 month phone call |
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