Dry Eyes ChronicNCT03089580
Intense Pulsed Light Study for Dry Eye Disease
A study testing Intense Pulsed Light Therapy in people with Dry Eyes Chronic, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eyes Chronic
- What is being tested?
- Intense Pulsed Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2017to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent;
- Diagnosed with evaporative dry eye disease with symptoms for 6 months or more;
- Able and willing to comply with follow-up visits, phone calls and intense pulsed light treatments;
- Agree to using an effective method of birth control during the course of the study;
- Agree to continue current dry eye treatments during the course of the study;
- Fitzpatrick skin scale of 1 (very fair) to 4 (olive) as determined by an investigator.
Who cannot join
- Darker skinned individuals defined by the Fitzpatrick scale 5 and 6 as determined by an investigator;
- Neurotrophic keratitis;
- Ectropion, trauma, or any other lid abnormalities;
- Previous diagnosis of Stevens Johnson syndrome or graft versus host disease;
- Ocular burn, active ocular infection, or active ocular inflammation;
- Currently pregnant or trying to become pregnant in the next 5 months;
Show all 18Show fewer
- Systemic conditions or currently taking medications which makes light therapy contraindicated (the use of doxycycline is allowed);
- Tattoos in the treatment area;
- Patients who have had intense pulsed light therapy, Lipiflow or Meibothermoflo within the past six months;
- Contact lens wear more than one time/week or history of refractive surgery;
- Glaucoma drop use
- Ophthalmic steroid use within the past 30 days;
- Punctal plugs if instilled within 30 days of the start of the study;
- Obvious asymmetry between the two eyes deemed significant by the investigators (such as punctal plugs or cautery in only one eye, etc);
- History of a trabeculectomy or tube surgery;
- Uncontrolled ocular or systemic disease;
- Ocular or eyelid surgery within the last 6 months;
- Any condition which leads the investigator to believe that the patient cannot comply with the study requirements and/or the patient may be placed at risk with participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, 48105
About this study
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.
Read the detailed description
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.
- Conditions
- Dry Eyes Chronic
- Being tested
- Intense Pulsed Light Therapy, Sham Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intense Pulsed Light TherapyDevice
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 TreatmentProcedure or surgery
The sham treatment will mimic the IPL treatment but no light will be delivered. Sham treatment will be administered 4 times throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Intense Pulsed Light Therapy |
| 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. Receives: Procedure: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start25 Mar 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eyes ChronicStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eversight Michigan/Michigan Eye Bank
- Responsible party
- Principal investigator, Sarah Wood, Ophthalmology, University of Michigan
- Investigators
- Sarah Wood, OD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089580
- Sponsor's protocol ID
- HUM00119518
- Status last verified
- Sep 2019
- First submitted
- 13 Mar 2017
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intense Pulsed Light Study for Dry Eye Disease
- ClinicalTrials.gov ID
- NCT03089580
- Acronym / sponsor ID
- HUM00119518
- Conditions
- Dry Eyes Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eversight Michigan/Michigan Eye Bank
- Study start
- 25 Mar 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Posted 8 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intense Pulsed Light Treatment | Experimental | Device: Intense Pulsed Light TherapyParticipants 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. |
| Sham Treatment | Placebo comparator | Procedure: Sham TreatmentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to provide informed consent;
- Diagnosed with evaporative dry eye disease with symptoms for 6 months or more;
- Able and willing to comply with follow-up visits, phone calls and intense pulsed light treatments;
- Agree to using an effective method of birth control during the course of the study;
- Agree to continue current dry eye treatments during the course of the study;
Key exclusion criteria (18 listed)
- Darker skinned individuals defined by the Fitzpatrick scale 5 and 6 as determined by an investigator;
- Neurotrophic keratitis;
- Ectropion, trauma, or any other lid abnormalities;
- Previous diagnosis of Stevens Johnson syndrome or graft versus host disease;
- Ocular burn, active ocular infection, or active ocular inflammation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intense Pulsed Light TherapyIntense 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. | Device | Intense Pulsed Light Treatment |
| Sham TreatmentThe sham treatment will mimic the IPL treatment but no light will be delivered. Sham treatment will be administered 4 times throughout the study. | Procedure or surgery | Sham Treatment |
Primary outcome
Tear Breakup Time Average
Time frame: 16.5 weeks
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.
Change in Scores of the Ocular Surface Disease Index Questionnaire
Time frame: 7 Months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Wood, OD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intense Pulsed Light Therapy in people with Dry Eyes Chronic, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear Breakup Time Average (time frame: 16.5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.