Intense Pulsed Light Study for Dry Eye Disease
Phase: NA
Conditions: Dry Eyes Chronic
Sponsor: University of Michigan

 
 
 
 
 
 
 
 
 
Official Title: Intense Pulsed Light Study for Dry Eye Disease 
 
NCT03089580 
 
Version Date: July 12th, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 

2 
 
A. Study Hypothesis and Objectives 
Dry eye disease (DED) is defined as a “multifactorial disease of the tears and ocular surface that results in 
symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular 
surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface[1].” 
This condition may also compromise surgical outcomes and patient satisfaction following cataract, refractive 
surgery[2], and corneal transplants[3].  DED can also impact everyday tasks such as reading, using a 
computer, driving, and watching television which can be up to three times more difficult[4].  Worker productivity 
is potentially adversely affected by DED and scales with disease severity[5]. In addition, depression is more 
prevalent in DED patients[6], further evidence of the disease’s debilitating effects.  Current treatments options 
are limited and a recent study found 75% of DED patients report inadequate relief despite treatment.  There is 
a critical barrier to provide efficacious treatment modalities to improve quality of life and to improve ocular 
surface health affected by DED. 
A new treatment called Intense Pulsed Light (IPL) shows promise to reduce signs and symptoms in preliminary 
studies.  IPL is a broad spectrum, non-coherent light treatment applied to the face and lower lids followed 
immediately by meibomian gland expression.  Unfortunately, rigorous peer-reviewed studies on IPL are largely 
missing.  Additional controlled, clinical studies are critical to better understand the potential of IPL to minimize 
objective measures of DED and improve patient quality of life.  
i. Study Aim  
The aim of this project is to rigorously evaluate the efficacy of IPL and to determine whether quality 
of life improvements can result from its implementation.  Our hypothesis is that IPL can provide 
reduction and potential elimination of symptoms for patients with the evaporative form of DED by 
improving the meibomian gland expression quality and quantity resulting in a more stable, intact 
tear layer.  We believe that the IPL treatment will deliver these results above and beyond 
meibomian gland expression alone. 
ii. Research Goals 
a. Substantiate the efficacy of IPL treatment for DED.  Our study will collect objective 
measures of DED disease at baseline and after each of four IPL treatments.  Our study 
design is a prospective, randomized, single masked trial.  This evidence will assist 
practitioners, patients, and third parties to understand the value of this procedure and who 
will most likely benefit. 
b. Determine the potential improvement in quality of life measures with IPL.  DED has a 
substantial negative impact on quality of life.  We will measure patient symptoms before and 
after each IPL treatment to assess the change in subjective quality of life measures using 
two validated questionnaires. 
c. Demonstrate that IPL treatment improves DED above and beyond meibomian gland 
expression alone.  There is limited evidence to support if the efficacy of IPL treatment is 
merely from IPL or the meibomian gland expression alone.  Our proposed study is intended 
to clarify whether adding IPL before meibomian gland expression improves the outcomes. 
To our knowledge, no previous studies have addressed this question.  
 
 
B. Background Information 

3 
 
Dry eye symptoms are common complaints in an estimated 25% of all eye doctors visits[7].  In the US 
population over 50 years of age, there are approximately 1.68 million men and 3.23 million women with 
diagnosed DED[8, 9].  The U.S. healthcare cost attributed to DED is approximately $3.84 billion[5].  The 
symptoms of this disease can range from a mild annoyance to extremely debilitating. Common symptoms 
include burning, stinging, tearing, blurred vision, foreign body sensation, contact lens intolerance, redness, 
chronic pain, and photophobia. Current treatments include topical tear supplements, environmental 
modifications to minimize tear evaporation, punctal occlusive treatments, ocular surface barriers, lid 
treatments, and immunomodulatory agents.  Despite these various treatments, inadequate relief is common 
and there is a critical barrier to provide efficacious treatment modalities to improve quality of life and to improve 
ocular surface health affected by DED.  We propose to test the hypothesis that IPL therapy will provide relief of 
evaporative DED symptoms by improving meibomian gland expression. 
IPL uses a xenon lamp that delivers pulsed, broad spectrum, non-coherent light with wavelengths from 500-
1200nm.  During this selective photothermolysis, the light is absorbed by chromophores in the skin, melanin, 
and hemoglobin and converted to heat[10]. 
IPL was first FDA approved in 1995 for dermatology[11] and is commonly used for treatment of facial rosacea, 
acne, and hair, wrinkle and lesion removal.  IPL for dry eye and ocular rosacea is currently off- label but is in 
the process of approval and is already approved for use in Europe and Australia.   
The exact mechanism for the impact of IPL on dry eye is not completely understood.  The theories include: 
ablation of superficial blood vessels which may deliver inflammatory mediators to the glands, connective tissue 
remodeling, reduction in eyelid bacterial and parasitic growth, such as demodex, and liquefication of the 
meibomian gland secretions[12].   
i. Preliminary Data 
We have previously performed IPL at our center on a total of 22 patients (age range 37-90, 18 
females/4 males).  Prior to treatment, the mean baseline total Ocular Surface Disease Index (OSDI) 
score was 23.79 and improved to 12.4 after three treatments (Figure 1).  The baseline mean TBUT 
(tear break-up time) was 1.05 seconds and improved to 5 seconds after three treatments (Figure 2). 
Both subjective and objective measures suggest a positive impact on DED with IPL treatment. 
 
ii. Safety Data  
In our preliminary treatments, no severe adverse events occurred.  One patient noted a small blister 
on the cheek that resolved after one day and they continued with future treatments.  Toyos[13] 
0
5
10
15
20
25
baseline
one
two
three
OSDI total score
Number of IPL treatments
Figure 1: Mean OSDI total score
0
1
2
3
4
5
6
baseline
one
two
three
TBUT (seconds)
Number of IPL treatments
Figure 2: Mean TBUT during IPL 

4 
 
noted of 91 subjects in a retrospective study, 14% had an adverse event that was most often mild, 
transient periorbital swelling and no serious events occurred.  This treatment appears to be safe. 
C. Study Design  
There are two classifications of DED: aqueous deficient and evaporative[1].  There is some overlap, but the 
vast majority of dry eye is evaporative.  Meibomian gland dysfunction (MGD) is the most common cause of 
evaporative dry eye. Intense Pulsed Light (DermaMed Solutions, Lenni, PA; Lumenis Ltd., Yokneam, Israel) 
will be applied to the lower eyelids and face with the intent to improve MGD.  We will test our hypothesis and 
complete our goals by conducting an intervention to one eye and the fellow eye will serve as a control to 
compare the effects of IPL in patients who have evaporative DED due to MGD.  
The study is a prospective, randomized, controlled, single masked trial.  The randomization is based on IPL 
treatment to one eye and sham treatment to the fellow eye.  The randomization will occur via a random number 
generator. The masking is based upon the cornea specialist’s examination.  The primary outcome measures 
include tear break up time (TBUT) and the Ocular Surface Disease Index (OSDI) symptom survey.  Exploratory 
outcome measures will include the National Eye Institute Visual Function Questionnaire (NEI-VFQ), changes in 
MGD quantitated by lid margin photography and meibography before and after IPL, and other standard dry eye 
clinical evaluation tools.   
All enrolled participants will be assigned a number, and the link between the number and participant will be 
secured. All data collection will comply with HIPPA guidelines. Data collection will include: clinical exam data, 
eyelid and facial photography, and meibography which will be de-identified. 
i. Participant Eligibility Criteria 
a. Inclusion Criteria 
1. Willing and able to provide informed consent; 
2. 18 years of age or older; 
3. Diagnosed with evaporative dry eye disease with symptoms for 6 months or more; 
4. Able and willing to comply with follow-up visits, phone calls and IPL treatments; 
5. Agree to using an effective method of birth control during the course of the study;  
6. Agree to continue current dry eye treatments during the course of the study; 
7. Fitzpatrick skin scale[14] of 1 (very fair) to 4 (olive) as determined by an investigator.    
b. Exclusion Criteria 
1. Darker skinned individuals defined by the Fitzpatrick scale 5 and 6 as determined by 
an investigator; 
2. Neurotrophic keratitis; 
3. Ectropion, trauma, or any other lid abnormalities; 
4. Previous diagnosis of Stevens Johnson syndrome or graft versus host disease; 
5. Ocular burn, active ocular infection, or active ocular inflammation;  
6. Currently pregnant or trying to become pregnant in the next 5 months; 
7. Systemic conditions or currently taking medications which makes light therapy 
contraindicated (the use of doxycycline is allowed); 
8. Tattoos in the treatment area; 
9. Patients who have had IPL, Lipiflow or Meibothermoflo within the past six months; 
10. Contact lens wear more than one time/week or history of refractive surgery; 
11. Glaucoma drop use  
12. Ophthalmic steroid use within the past 30 days; 
13. Punctal plugs if instilled within 30 days of the start of the study; 

5 
 
14. Obvious asymmetry between the two eyes deemed significant by the investigators 
(such as punctal plugs or cautery in only one eye, etc); 
15. History of a trabeculectomy or tube surgery; 
16. Uncontrolled ocular or systemic disease; 
17. Ocular or eyelid surgery within the last 6 months; 
18. 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. 
 
ii. Study Procedures 
Potential participants will provide written informed consent prior to any baseline testing (visit 1). All 
participants will be asked to complete 5 in-clinic study visits and 2 telephone calls over the course 
of approximately 7 months. Women of child bearing potential will be asked to provide a urine 
sample for a pregnancy test at the baseline visit. The investigator may ask for an additional 
pregnancy test at subsequent visits if they deem necessary.  
The patients will be evaluated at baseline (visit 1) and return once a month for a total of 5 months 
(visits 2, 3, 4 and 5). They will be asked to complete study testing and will be evaluated by a 
masked corneal specialist at each visit. The phenotypic characterization for dry eye will include the 
following tests for both eyes: tear break-up time (TBUT) in triplicate using a timer, lissamine green 
staining of conjunctiva (grading 1-4, noted temporally and nasally), corneal staining with fluorescein 
(grading 1-4, breaking the cornea into 4 sections), meibomian gland health with the Meibomian 
Gland Evaluator (TearScience, Morrisville, NC), tear osmolarity, and 5-minute Shirmers under 
anesthetic using a timer. All patients will also undergo standardized slit lamp eyelid margin 
photography that includes upper and lower lids, have facial photography and meibography of the 
lids. Other testing that will be completed at certain time points include pinholed ETDRS visual acuity 
testing and the measurement of intraocular pressure. We will also obtain information about the 
participant’s medical history (review of systems), and current ocular and systemic medications.  
All participants will take the Ocular Surface Disease Index (OSDI)[15] and 25-item National Eye 
Institute Visual Functioning Questionnaire (NEI-VFQ)[16]. Both questionnaires will be administered 
at each visit. These surveys do not allow for separating the response between each eye. 
The participants will also be contacted over the phone by a member of the study team 
approximately 1 week and 7 months after their baseline visit. 
iii. Study Design 
Once the patient has signed informed consent, completed the baseline testing, and is determined to 
be eligible by an investigator, they will have one eye randomized to receive the IPL treatment and 
the fellow eye will receive a sham treatment. 
a. Intervention with IPL 
IPulse Quadra Q4 and Lumenis M22 devices will be provided by the cornea clinic at Kellogg 
Eye Center. 
Prior to treatment, eye shields will be placed over both eyes of the participant. On the side 
that was randomly selected to receive the IPL treatment, ultrasound gel will be applied 
around the eye, lower eyelid, cheek, side of nose and temple. The PI will then administer 
approximately 15 light spots in areas where the ultrasound gel was applied. 

6 
 
All IPL treatments will be performed by the same investigator, the PI, who will not be 
masked. Each subject’s eyes will be randomized with one eye/side of the face receiving IPL 
treatment (Figure 3), and the fellow eye serving as a control. At the first IPL treatment, the 
energy level (range of 8-18 joules) will be individually determined based the patient’s skin 
Fitzpatrick scale phototype. The IPL instrument, Quadra Q4®, includes four pulse levels (1-
4) each with six sublevels (A-F).  The pulse intensity is inversely related to the skin 
phototype scale, and as noted in subject inclusion and exclusion criteria above, we will only 
treat patients who are phototype 1 through 4. The sublevel D is used for the initial treatment 
unless the patient cannot tolerate it and then a lower sublevel will be used.  Future 
treatments sublevels will be increased gradually unless the examiner determines this is 
unsafe for the patient.   
The Lumenis M22 IPL device requires the user to input fluence (joules/cm2) level prior to 
treatment. The below graph shows the fluence levels of the Dermamed Quadra Q4® that 
coorelate to the fluence levels of the Lumenis M22. 
Fitzpatrick Skin type 
  
1 
2 
3 
4 
A 
10J/cm2 
9J/cm2 
8J/cm2 
8J/cm2 
B 
11J/cm2 
10J/cm2 9J/cm2 
8.5J/cm2 
C 
12J/cm2 
11J/cm2 9.5J/cm2 
9J/cm2 
D 
13J/cm2 
12J/cm2 10J/cm2 
9.5J/cm2 
E 
14J/cm2 
13J/cm2 10.5J/cm2 10J/cm2 
F 
15J/cm2 
14J/cm2 11J/cm2 
10.5J/cm2 
 
 
 
 
 
 
 
 
 
b. Sham Treatment 
With the eye shields still in place, the fellow eye will be treated with approximately 15 spots 
of pressure around the eye, lower eyelid, cheek, side of nose and temple with the IPL 
device. No light energy will be applied. The PI will only place the device on the participant 
and press to mimic actual IPL treatment. Ultrasound gel will be applied to these areas prior 
to the sham treatment to prevent unmasking of the participant.  
c. Post-Treatment 
After the IPL and sham treatments have been completed, the eye shields will be removed, 
and the face cleaned. The upper and lower lids of both eyes will be expressed with a 
meibomian gland expressor while being positioned at the slit lamp. 
 
Figure 3. IPL treatment.  After placing eye shields, an ultrasound gel is 
applied. Treatments spots are done around the eye, lower eyelid, 
cheek, side of nose and temple. 

7 
 
After treatment, as recommended by the manufacturer, each subject will be asked to use 
ketorolac twice a day for three days and to wear SPF 30 sunscreen for one week. During 
the course of the treatment period, any adverse events will be noted per the adverse 
reporting guidelines outlined in section D. 
d. 1 Week Safety Follow Up Phone Call (+/- 2 days) 
Approximately one week after the participants have completed the baseline visit and 
received the IPL and sham treatments, a member of the study team will contact the 
participants to answer any questions and to document any adverse events. 
e. Follow Up Visits (+/- 10 days) 
Participants will return to the clinic for 4 additional visits after the baseline visit (visit 1).  
At visits 2, 3, and 4, participants will be evaluated by a corneal specialist who is masked to 
the IPL treatment randomization, complete the testing outlined in the schedule of events 
(appendix A), and receive IPL and sham treatments accordingly. Participants will receive a 
total of 4 IPL and sham treatments throughout the duration of the study. 
Participants will be asked to return to the clinic approximately 16.5 weeks after their baseline 
visit to complete visit 5. They will complete the testing outlined in the schedule of events but 
will not receive IPL or sham treatments. 
f. 7 Month Follow Up Phone Call (+/- 5 days) 
After the participant’s final visit (visit 5) a member of the study team will contact the 
participant approximately 7 months after their baseline visit. Participants will be asked to 
complete the OSDI and NEI-VFQ questionnaires over the phone. After completion of the 
questionnaires, the study team member will inform the participant of which eye received the 
IPL treatment and which eye received the sham treatment. Also during this call, the 
participants will be offered to complete an optional visit. At this optional visit they will be 
asked to complete the testing outlined in the schedule of events and will be offered IPL 
treatment on both eyes free of charge. Patient’s that do not wish to come in for the optional 
visit and IPL treatments, end their participation after completing the questionnaires, if they 
did not choose to end it sooner. 
D. Reporting Procedures 
i. Adverse Events 
a. Adverse events (AEs) and complications determined by the investigator to be “possibly”, 
“probably” or “definitely” related to the IPL treatment or study procedures will be recorded 
and reported to the IRB according to their reporting guidelines.  
b. Any AE that is determined by the investigator to meet the definition of an unanticipated 
problem involving risks to subjects or others will be reported within 7 days to the IRB if is 
determined to be a serious problem. If the unanticipated problem is determined to be non-
serious, it will be reported to the IRB within 14 days.  
ii. Serious Adverse Events 
a. Any AE which meets the FDA definition of serious and determined by the investigator to be 
“possibly”, “probably” or “definitely” related to the IPL treatment or study procedures will be 
recorded and reported to the IRB within 7 days. 

8 
 
iii. Other Reportable Occurrences 
a. All protocol deviations will be reported to the IRB at the continuing renewal. 
b. Any privacy violation or breach of confidentiality will be reported to the IRB within 7 days and 
within 24 hours to the UMHS Privacy Office.  
iv. Unmasking  
a. Unmasking of the participant will occur after completion of the ODSDI and NEI-VFQ 
questionnaires during the 7 month follow up call. 
b. Unmasking may occur at any time point throughout the trial if it is determined by an 
investigator to be in the best interest of the participant. 
E. Statistical Methods 
i. Sample Size and Power 
The primary study outcome (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.  
Based on our preliminary data, other published dry eye studies[17], and recent meeting abstract 
(ASCRS 2014; Gupta PK et al.) the expected, 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.  We will recruit 30 subjects allowing for an anticipated 10% 
drop-out rate. 
All three study goals have a paired design wherein the first two goals contrast pre- to post-treatment 
measures in the treated eye, and the 3rd compares the treated eye to the control eye.  The primary 
analysis for each objective will apply the paired, Student’s t-test to contrast the continuous outcome 
variables for efficacy assessment (TBUT, Shirmer’s test, corneal staining) in the treated eye (Goal 
1) and the patient’s quality of life (Goal 2), and the treated vs. control eye measures (Goal 3) from 
pre-treatment to post-4th treatment times. If the parametric assumptions of this test are not met, the 
non-parametric equivalent test, the Wilcoxon signed rank test, will be applied. In all cases, the null 
hypothesis to be tested is one of no change from pre- to post treatment, with a Type I error 
probability of 0.05 for the primary outcome assessment.  The pattern of change over the 4 
treatment visits in these continuous variables will be assessed using mixed, linear regression. SAS 
version 9.4 statistical software (SAS Institute, Cary, NC) will be used. 
F. Summary and Long-Term Plan 
Dry eye disease is a prevalent ocular condition with inadequate treatments available for proper relief.  IPL has 
the potential to help those with evaporative dry eye due to meibomian gland dysfunction. This is a new 
treatment that needs to be studied with more rigor to understand the magnitude of the benefit for the relief of 
symptoms and reduced clinical signs.  This study will provide answers to these questions in a prospective, 
masked design with the hope of providing an improved quality of life to those with DED. 
We plan to use the anticipated results from this pilot study to apply for funding for a larger, prospective study 
on a specific population at high risk for severe DED, those with graft versus host disease.  These patients often 
have extreme dry eye due to damage to the lacrimal and meibomian glands.  Kellogg Eye Center has a large 
volume of these patients from the University of Michigan Cancer Center.  Often the current dry eye treatments 
are not sufficient to effectively treat their DED.  There are currently no studies on the efficacy of IPL on this 
population.  This project would require additional funding through another grant.  With addition funding, we also 

9 
 
hope to purchase a meibographer to image the entire meibomian glands in the tarsal plate to detect atrophic 
glands which are unlikely to respond to treatment. 
G. References: 
 
1. 
The definition and classification of dry eye disease: report of the Definition and Classification 
Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf, 2007. 5(2): p. 75-92. 
2. 
Bron, A.J., et al., Rethinking dry eye disease: a perspective on clinical implications. Ocul Surf, 2014. 
12(2 Suppl): p. S1-31. 
3. 
Kumar, V. and A. Kumar, Immunological aspects of corneal transplant. Immunol Invest, 2014. 43(8): p. 
888-901. 
4. 
Miljanovic, B., et al., Impact of dry eye syndrome on vision-related quality of life. Am J Ophthalmol, 
2007. 143(3): p. 409-15. 
5. 
Yu, J., C.V. Asche, and C.J. Fairchild, The economic burden of dry eye disease in the United States: a 
decision tree analysis. Cornea, 2011. 30(4): p. 379-87. 
6. 
Labbe, A., et al., Dry eye disease, dry eye symptoms and depression: the Beijing Eye Study. Br J 
Ophthalmol, 2013. 97(11): p. 1399-403. 
7. 
Gayton, J.L., Etiology, prevalence, and treatment of dry eye disease. Clin Ophthalmol, 2009. 3: p. 405-
12. 
8. 
Schaumberg, D.A., et al., Prevalence of dry eye disease among US men: estimates from the 
Physicians' Health Studies. Arch Ophthalmol, 2009. 127(6): p. 763-8. 
9. 
Schaumberg, D.A., et al., Prevalence of dry eye syndrome among US women. Am J Ophthalmol, 2003. 
136(2): p. 318-26. 
10. 
Piccolo, D., et al., Unconventional use of intense pulsed light. Biomed Res Int, 2014. 2014: p. 618206. 
11. 
Wat, H., et al., Application of intense pulsed light in the treatment of dermatologic disease: a systematic 
review. Dermatol Surg, 2014. 40(4): p. 359-77. 
12. 
Vora, G.K. and P.K. Gupta, Intense pulsed light therapy for the treatment of evaporative dry eye 
disease. Curr Opin Ophthalmol, 2015. 26(4): p. 314-8. 
13. 
Toyos, R., W. McGill, and D. Briscoe, Intense pulsed light treatment for dry eye disease due to 
meibomian gland dysfunction; a 3-year retrospective study. Photomed Laser Surg, 2015. 33(1): p. 41-6. 
14. 
Roberts, W.E., Skin Type Classification Systems Old and New. Dermatologic Clinics, 2009. 27(4): p. 
529-533. 
15. 
Schiffman, R.M., et al., Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol, 
2000. 118(5): p. 615-21. 
16. 
Mangione, C.M., et al., Psychometric properties of the National Eye Institute Visual Function 
Questionnaire (NEI-VFQ). NEI-VFQ Field Test Investigators. Arch Ophthalmol, 1998. 116(11): p. 1496-
504. 
17. 
Craig, J.P., Y.H. Chen, and P.R. Turnbull, Prospective trial of intense pulsed light for the treatment of 
meibomian gland dysfunction. Invest Ophthalmol Vis Sci, 2015. 56(3): p. 1965-70. 
 
 
 
 
 
 
 
 

1 
 
Appendix A: Schedule of Events 
Procedure 
Baseline 
(Visit 1) 
1 week 
phone call 
(+/- 2 days) 
Visit 2, 4.5 
weeks (+/- 
10 days) 
Visit 3, 8.5 
weeks (+/- 
10 days) 
Visit 4, 12.5 
weeks (+/- 
10 days) 
Visit 5, 16.5 
weeks (+/- 
10 days) 
7 month 
phone call 
(+/- 5 days) 
Optional 
Visit (e) 
Informed Consent (a) 
X 
 
 
 
 
 
 
 
Pregnancy Test (a) 
X 
 
 
 
 
 
 
 
Review of Systems (a) 
X 
 
X 
X 
X 
X 
 
 
Ocular and Systemic Medications (a) 
X 
 
X 
X 
X 
X 
 
 
Adverse Event Assessment (a) 
 
X 
X 
X 
X 
X 
 
 
Pinholed ETDRS Visual Acuity (a) 
X 
 
X 
X 
X 
X 
 
X(f) 
OSDI Questionnaire (a) 
X 
 
X 
X 
X 
X 
X 
 
NEI-VFQ Questionnaire (a) 
X 
 
X 
X 
X 
X 
X 
 
Tear Osmolarity (a) 
X 
 
 
 
 
X 
 
 
Eyelid Photography at Slit Lamp (a) 
X 
 
 
 
 
X 
 
 
Facial Photography (a) 
X 
 
 
 
 
X 
 
 
Meibography (a,c) 
X 
 
 
 
 
X 
 
 
TBUT (b) 
X 
 
X 
X 
X 
X 
 
X 
Fluorescein Staining (b) 
X 
 
X 
X 
X 
X 
 
X 
Lissamine Green Staining (b) 
X 
 
X 
X 
X 
X 
 
 
Meibomian Gland Evaluation (b) 
X 
 
X 
X 
X 
X 
 
 

2 
 
 
** All tests are completed on both eyes except that IPL treatment is performed on one eye and the sham treatment is performed on the other. 
** Fluorescein staining, lissamine green staining and Meibomian gland evaluation are to be completed right eye and then left eye. 
a- Indicates that it is to be completed by study coordinator/technician (excludes the optional visit). 
b- Indicates that it is to be completed by a masked corneal specialist (excludes the optional visit). 
c- Indicates that it is to be completed by the unmasked PI. 
d- Unmasking of the participant will occur after completion of the ODSDI and NEI-VFQ questionnaires.  
Unmasking may occur at any time point throughout the trial if it is determined by an investigator to be in the best interest of the participant.  
e- Can be completed entirely by Unmasked PI 
f- 
ETDRS visual acuity testing may be substituted for standard Snellen visual acuity at optional visit 
 
 
 
 
 
 
 
Schirmers Test (c) 
X 
 
X 
X 
X 
X 
 
 
Intraocular Pressure Measurement (c) 
X 
 
X 
X 
X 
X 
 
 
Randomization (c) 
X 
 
 
 
 
 
 
 
Unmasking (d) 
 
 
 
 
 
 
X 
 
IPL and Sham Treatment (c) 
X 
 
X 
X 
X 
 
 
X (IPL to 
both eyes) 
Expression of Upper and Lower Lids (c) 
X 
 
X 
X 
X 
 
 
X 
Begin ketorolac Instillation (twice a day 
for three days)  (c) 
X 
 
X 
X 
X 
 
 
X