N/A
N=14
Intense Pulsed Light Study for Dry Eye Disease
Dry Eyes Chronic
Bottom Line
View on ClinicalTrials.gov: NCT03089580 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Tear Breakup Time Average — 3.3; 3.0; 4.1; 4.5 Seconds — p=0.3
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intense Pulsed Light Therapy (Device); Sham Treatment (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tear Breakup Time Average |
3.3; 3.0; 4.1; 4.5 | 0.3 |
| PRIMARY Change in Scores of the Ocular Surface Disease Index Questionnaire |
29.7; 25.6; 23.6; 20.7; 23.7; 22.2 | 0.2026 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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;
- 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.
Data sourced from ClinicalTrials.gov (NCT03089580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.