Insite Invision Clinical Phase 3 Study Subject (Azasite Plus ISV-502)

[thman558]

Insite Invision

Clinical Trial Phase 3

Summary of my history suffering from MGD

Today going into my doctor’s appointment my meibomian glands were raw and dry. After my evaluations the ophthalmologist specifically said I have acne inside my meibomian glands, however I have never had acne in my life. The inflammation from the acne was not allowing me to produce sufficient oil, thus creating inflammation of my upper eyelid and dryness. The doctor’s specific words describing my meibomian glands were to the extent of them being described as “raw”. This was a very different concept for me to grasp. I have been suffering from meibomian gland issues for the past 4 years. I am only 24 years old and I can’t understand why I’m suffering at such an early age of my life. I have no abnormal Sx’s in my left eye. My Sx’s consist of having a gritty feeling inside my right eye with frequent, sometimes constant inflammation directly above my eyelashes. When the flare-ups transpire I see tiny white dots above each individual eyelash line and they are parallel to one another and a line above my eyelashes is red (due to infection I’m sure). My Sx’s are at its worst if I am in a windy or dry environment. I have good hygiene and I take care of myself. I use warm compresses 3x+ daily associated with lid scrubs with Johnson’s baby shampoo in the morning and evenings. I am a very active male approximately 5’11 in height and I weigh 175Lbs. My past treatments have consisted of Tobramycin and dexamethasone, Azasite, Ak-Poly-Bac ointment, minocycline and doxycycline. My personal opinion is that Azasite has been the best medication I have used thus far. The only negatives I had with the product was when I would apply the drops to my eyelashes, it seemed to feel like my eyelid would get crusty and give me the feeling of debris in my eyelid and sometimes my inflammation increased, however this was not consistent. I am also aware that these side effects could be from my eyelid developing an infection and when medicine is initially applied, that’s why I get the flare ups. This medication was the only product on the market that would give me some sort of relief and give me a positive outlook on life. Suffering from MGD is very difficult mentally. Having the constant feeling of having irritation in your eyelid is unbearable at times, however I have adapted and am used to the feeling. I pray and hope every day there is a cure for this disease because I know I would be more optimistic and portray all the confidence that I have been hiding. Thank you insite Invision for doing the research to help every person suffering from this disease.

Clinical Trial:
This clinical trial consists of random patients suffering from blepharitis/MGD. If you qualify for the study, you will be assigned by chance(like the flip of a coin) to receive one of four study drugs: 1) ISV-502 (a combination of Azasite and Dexamthason), 2) Azasite, 3) Dexamethasone or 4) Vehicle for 14 days. You will be randomly assigned to the ISV-502, azasite, dexamethasone and vehicle groups in a 2:1 2:1 ration, respectively, according to a computer generated central randomizations schedule. There is a 33 % chance you will receive the study drug, ISV-502 (antibiotic and anti-inflammatory), a 16% chance you will receive azasite (anti biotic only), a 33% chance you will receive Dexamethasone (anti-inflammatory), and 16 % chance you will receive vehicle (liquid that does not contain any drugs). Neither you or the doctor will know which eye drop you have, however it will be available to the Dr in case of a, emergency.

(I am off all medications except for the study drug)

Day 1- I took my first sample at 9am: I felt 80% relief of all Sx’s by 10am. I began feeling my eyelid swell around 7:30pm, however it was not as severe as it normally is. Im not sure if this is because of the initial application to the drug, “my body not being used to it”. I took my second sample at 8:45pm and went to bed shortly afterwards.

Day 2- When I woke up, my eyelids were not as dry, nor as swollen as they typically are. I applied Day 2 drops at 9:04am after cleaning my eyelid with warm compresses and lid scrubs. It is currently 10:37am and I feel some inflammation inside my eyelid, but I do not feel that grittiness that usually transpires daily. I applied my eyedrops at 9:15 PM and my eyes feel amazing so far. The best way to describe this medication is hydrating, purifying, and soothing to the eyelid. There is still minor inflammation, however I feel the medication is slowly dissipating those areas. I am still not certain if I have received the study drug at this point. I know it’s not azasite due to my experience with it, but the other choice of drug can be dexamethasone. At this point I am not certain, but all I can say is progression is being made. For those wondering how I apply the medication it’s simple. Every morning and night, 12 hours apart I apply a drop of the study drug on a clean finger and smear it along the eyelash margin.

Day 3- Today upon waking up from bed I noticed my eyes/eyelids were not red, but they had the same tone as they should. I'm not sure if insite invision included some sort of hydro-cortisone drop in this new study as well, but my skin does not feel dry at all. For those who suffer from dry eye due to dermatitis/eczema/rosacea I think this new drug would be highly effective. The only notice I had was in my right eye (which was diagnosed as severe for MGD) seemed to crust in the outside corner of my eye during my sleep. There were no flakes along the eyelashes that I was aware of. I woke up and at 9am I did my routine warm compress and lid scrubs. I applied the application around 9:10am and I am feeling very good today. I still do not have that gritty feeling that was almost constant the past 4 years of my life. The inflammation is there, but it still continues to dissipate every day and is minimal compared to the norm. I know alot of members complained of the regular azasite burning upon instilling the drop inside the eye.. but with this medication I have felt no burning or that (crusty) feeling along the eyelid margin. Yesterday I took my son out to the swimming pool for about an hour, the temp in Sacramento must have been a dry 80 degrees.. But I felt fine and my eyelid did not flare up like it typically would. Right now its 9:30am so I will finalize how my day went tonight around 9:30pm... After my initial drops at 9am I continued my day as I normally would. Around 3pm I decided to wash my car.. With it being so hot outside I was sweating pretty heavy and I felt my eyelid begin to inflame again.. I'm not sure how the sweat correlates with the inflammation, but it was a minor flare up (not the usual intensity I'm used to). At 8pm the I didn't really notice the inflammation and I decided to go in my hot tub for about 35min and just chill before the long week of work.. After a moment of relaxation to myself I did my normal routine with warm compress and lid scrubs. I have the medicine currently on and may I say my eye feels extremely good. It feels hydrated, smooth, and when I look around in a circular motion with my head stable I feel absolutely no grittiness. Today is the end of day 3 and I am curious as to where I will be at day 14.. So once again.. To be continued..

to be continued...

[thman558]

Day 4: Today I woke up at 5am for work.. This is pretty early compared to my average 8am wake up time during my days off. My right eye had minor inflammation, however I noticed crustiness on the outside margin of my right eye again. This was more extreme than usual. I cleaned the outside corner of my eye, but I did not touch the lid itself because the medication was still applied from the previous night. I waited until 9:20 to quickly clean the debris off my eyelids and apply the medication. I work in a hospital, which is very dry (air condition dryness). Today wasn't very good at all.. Throughout the day my inflammation persisted and the gritty feeling came back. I was tempted to do a warm compress and re-apply the medication but I did not do anything. I pretty much dealt with it the whole day. I came home from work and did school work for about 2 hours. My eyelid was pretty much the same until I applied the 2nd phase of the medication at 8:45. My eyes felt better at this point, they had the rejuvenated feeling. I went to bed shortly afterwards hoping for a better following day.

Day 5:Today when I woke up I noticed even more crustiness on my outside margin of my eyelid, however the inflammation was almost gone! I was surprised and not really sure what to think at first. I had a doctors appt at 9:30am which I was looking forward to. After the evaluation which was an examination of my eyelid margin, and he put these drops in my eye (i wasn't sure what it was, but it felt like all my blood vessels popped out in my eye, I had a really tense feeling. He said some numbers to the employee taking notes in the back round.. On the very first day I remember him saying 16 in my left eye and 19 in my right, however today it was 16 in my left and 16 in my right. After the evaluation he told me he thinks the medication was working.. He joked and said hopefully its not a placebo effect (gosh i hope not).. He told me to continue what I was doing because it was working. I went to work afterwards and I did not have any flare ups at all. My eyelid was calm the whole day.. I just re applied my nightly medication and my eye feels wonderful.. I need to pick up my wife from the airport in 5 min, so this was a quick vague description of my last 2 days.. My initial message I wrote didnt post because of some glitch.. (I was sad to re-write this).. anyways to be continued..

[thman558]

Continued

Day 6- Today I began my morning at 5am, When I awoke I noticed I had more flaking along my eyelashes than normal along with inflammation. There was no crusting on the outside of my eyelid margin.. Very weird how the inflammation and the outside crusting of the eyelid margin correlate with one another.. I got ready for work and began my day. At 8:45 I applied the medication to my eyelid margin, however I didn't get that instant soothing feeling and anti inflammation I was used to. I was hoping my Sx's would get better however I began felling some grittiness in my right eye. Overall today wasn't very good, similar to Monday when I began work. My confidence crashed today and I'm not sure if this is due to the breakdown of some sort of bacteria that has bursted in my eye, or plain inflammation in general. I am trying to catch some pattern of this disease. My diet wasn't very healthy today and I am not sure if that would contribute.. I didn't eat breakfast, I had a marie calendar meal for lunch with some whole grain snacks. I had salad and lasagna with garlic bread for dinner. I applied my 2nd application of the medication at 9pm and at the moment (currently 10:14) I feel good actually. I do not feel much inflammation and zero grittiness. When I spoke with my doctor about my experiences through day 5 he told me its too soon to judge how the medication is going to react, but at day 14 it should be at its peak. Rest aside i'm hoping this medication has an all out war and rids this infection/disease. I will post tomorrow to continue my progress thus far on the trial drug. To be continued....

[dave25]

Just a quick thought, are you still using baby shampoo to clean your lids? I used baby shampoo for over 2 years per my doctors request. Once I stopped using baby shampoo and just used either warm water or saline rinse to clean my lids my eyes improved a lot. Anyway, keep up the posts! I am interested in finding out how this works for you.