Dry Eyes Chronic
Conditions
Brief 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.
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.
Interventions
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.
PROCEDURESham 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.
Sponsors
Eversight Michigan/Michigan Eye Bank
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Breakup Time Average | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
14 participants were recruited. Each participant received the Intense Pulse Light treatment in one eye and the sham treatment in their other eye.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Intense Pulsed Light Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 1 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
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.
Time frame: 7 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intense Pulsed Light Treatment | Change in Scores of the Ocular Surface Disease Index Questionnaire | Visit 1 at Baseline | 29.7 score on a scale | Standard Deviation 21.6 |
| Intense Pulsed Light Treatment | Change in Scores of the Ocular Surface Disease Index Questionnaire | Visit 2 at 4 weeks | 25.6 score on a scale | Standard Deviation 17.2 |
| Intense Pulsed Light Treatment | Change in Scores of the Ocular Surface Disease Index Questionnaire | Visit 3 at 8 weeks | 23.6 score on a scale | Standard Deviation 20.1 |
| Intense Pulsed Light Treatment | Change in Scores of the Ocular Surface Disease Index Questionnaire | Visit 4 at 12 weeks | 20.7 score on a scale | Standard Deviation 18.6 |
| Intense Pulsed Light Treatment | Change in Scores of the Ocular Surface Disease Index Questionnaire | Visit 5 at 16.5 weeks | 23.7 score on a scale | Standard Deviation 19.8 |
| Intense Pulsed Light Treatment | Change in Scores of the Ocular Surface Disease Index Questionnaire | 7 month phone call | 22.2 score on a scale | Standard Deviation 19.5 |
p-value: 0.2026paired t test
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.
Time frame: 16.5 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intense Pulsed Light Treatment | Tear Breakup Time Average | Visit 5 at 16.5 Weeks | 4.1 Seconds | Standard Deviation 2.3 |
| Intense Pulsed Light Treatment | Tear Breakup Time Average | Visit 1 at Baseline | 3.3 Seconds | Standard Deviation 1.3 |
| Sham Treatment | Tear Breakup Time Average | Visit 5 at 16.5 Weeks | 4.5 Seconds | Standard Deviation 2.5 |
| Sham Treatment | Tear Breakup Time Average | Visit 1 at Baseline | 3.0 Seconds | Standard Deviation 1.5 |
Comparison: The primary study outcome of pre to post change in TBUT within the treated eye and also the untreated, control eye dictated the use of a paired statistical approach to sample size estimation. Clinically relevant pre to post TBUT increase of 3 seconds with a standard deviation of 4.5 seconds was used. Type I and II error estimates used were standard for a non-pivotal study, 0.05 \& 0.20. The estimated the sample size needed detect this difference in TBUT is 27 subjects.p-value: 0.3paired t test