If you suffer from dry eye we are looking for you! Dr MacInnis is currently doing a study on dry eye patients, particularly for those with dry eye caused by Rosacea. If you think you may be a candidate, contact our office for more information.
During this study there will be different measurements taken, including pictures of the glands that produce your tears and the saltiness of your tears. You will be provided with multiple products for the first month, after which there will be an E>Eye treatment. There will be another E>Eye treatment two weeks later, and another a month after that. All products and tests will be at no charge which has a retail value of up to $690! There will be a fee for the E>Eye treatments of $450.
The full information on the study follows:
What is the purpose of this study?
This study is being conducted to understand the benefits of E>Eye a medical device that has been specifically designed for treating dry eye syndrome due to Meibomian Gland Dysfunction.
The device generates Intense Regulated Pulsed Light by producing perfectly calibrated light pulses. The energy, spectrum and time period are precisely set to stimulate the Meibomian glands in order for them to return their normal function.
What will I have to do during the study?
The study involves If you decide to participate in this study, you will be asked to do the following:
- The study will involve 5 total visits over 105 days.
- At each of the visits you will be asked to complete questionnaires as well as allow the Dr to perform diagnostic testing on your eyes. These diagnostic tests will help us assess your signs and symptoms of Dry Eye.
- At the first visit you will be provided drops, wipes and a heating face mask to use at home for 30 days.
- During the entirety of the 105 days you will be required to record your compliance to the Dr prescribed use of drops, wipes, heating mask and Omega 3s if applicable.
- During the second, third and fourth visit, in addition to the questionnaires and diagnostic testing, you will have an Intense Regulated Pulse Light treatment performed on both eyes. This treatment is non-invasive, entirely painless, and completely harmless to the eyes.
- If you have signs of rosacea you will have additional Intense Regulated Pulse Light treatments performed on your cheeks and nose.
- After the treatment, the Dr will express the glands on your eyelids to ensure the lipid expressed from the glands is flowing.
- After each of these treatments you will be provided with drops and wipes to use at home between treatments.
How many individuals will participate in the study and how long will the study approximately last?
There will be up to 25 patients participating in this study, the study will last a total of 105 days for each patient.
What are the potential risks or discomforts involved?
All testing will be completed by study staff with training and experience in completing the procedures. There are no anticipated risks associate with any of the standard of care testing in this study. You may feel some discomfort during some of the testing. You should call the study doctor or staff as soon as possible if, after this study, you feel any ongoing discomfort.
How will privacy and confidentiality (identity) be protected?
Federal law requires that certain information about individuals who participate in research studies be kept confidential. Any information that identifies you personally such as your name, address and social security number, any medical or mental health record(s), or test result(s), that may have this information on it will be kept confidential by the study clinic. According to the same law you may see and review your medical records at any time. However, in a research study, you may not see the study results or other data about the study until after the research is completed unless the study doctor decides to share this information with you. In that case the identity of other participants will be protected.
If you join this study, the following individuals or entities may have access to your records:
- The study doctor listed on this consent form and other personnel involved in this specific study.
- The study sponsor, I-MED Pharma Inc., and its staff and designees.
- Any other person or agency required by law.
The data collected in this study will be provided to the study sponsor and other entities noted above.
The results of tests performed as part of this study may be included in your medical records. The information from this study may be published in scientific journals or presented at scientific meetings but you will not be identified in these publications and/or presentations.
After your test results (without identifying information) is shared with others, including the study sponsor, it may no longer be protected by the Privacy Rule. The people who receive this information may use it in ways not discussed in this form and may disclose it to others. The study sponsor will use and disclose information about you only for research or regulatory reasons or to publish results. However, your personal information will not be shared in any forms, reports, or publications.
What if I am injured as a result of being in this study?
If you experience a study-related injury, any necessary medical care will be provided. A study-related injury is a physical injury or illness resulting to you that is directly caused by any procedure used in this study that is different from the testing you would receive if you were not participating in a research study. If you are physically injured due to any testing properly given under the plan for this study, medical expenses for treating the injury will be billed to your insurance. You should be aware that some costs may not be covered by your insurance. There is no plan to provide compensation for loss of income, lost time from work, personal discomfort, or for injuries or problems related to your underlying medical condition(s).
If you receive a bill related to a study-related injury that seems wrong, please discuss it with the study doctor or staff.
Will I be paid for being in this study?
You will not receive payment for your participation in this study, however you will receive drops, wipes and and I-Relief mask at no charge for the duration of the study.
Your participation in this study is completely voluntary. You may stop participation in this study at any time, or refuse to continue testing, or ask any questions for any reason, without it being held against you.
If you stop participating in the study, further collection of information will be stopped, but the information that has already been collected may still be used. Note: all study data will be collected on the day of the test and further follow-up is not expected.
Should you decide to withdraw from the study, please be sure to inform the study doctor.
Can I be removed from the study?
Your participation in this research project may be terminated by the study doctor or study sponsor without your permission for any reason that they feel is appropriate.