CLINICAL TRIAL

Dextenza 0.4Mg Ophthalmic Insert for Inflammation

Recruiting · 18+ · All Sexes · Los Angeles, CA

This study is evaluating whether DEXTENZA, a sustained release dexamethasone 0.4 mg insert following corneal transplant surgery (PKP, DSEK, D

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About the trial for Inflammation

Eligible Conditions
Corneal Defect · Corneal Transplant · Corneal Edema · Inflammation · Penetrating KeratoPlasty · Anterior Chamber Inflammation · Eye Pain

Treatment Groups

This trial involves 3 different treatments. Dextenza 0.4Mg Ophthalmic Insert is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Experimental Group 1
Dextenza 0.4Mg Ophthalmic Insert
DRUG
+
Prednisolone Acetate 1% Oph Susp
DRUG
Experimental Group 2
Dextenza 0.4Mg Ophthalmic Insert
DRUG
+
Prednisolone Acetate 1% Oph Susp
DRUG
Experimental Group 3
Dextenza 0.4Mg Ophthalmic Insert
DRUG
+
Prednisolone Acetate 1% Oph Susp
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Prednisolone acetate
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Any person who is 18 years old or older is legally allowed to vote. show original
Corneal transplant surgery can be scheduled in advance show original
The subject is willing and able to comply with all clinic visits and study related procedures. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Assessed on Day 30, 60 and 90
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Assessed on Day 30, 60 and 90.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Dextenza 0.4Mg Ophthalmic Insert will improve 2 primary outcomes and 4 secondary outcomes in patients with Inflammation. Measurement will happen over the course of Assessed on Day 1 and 7.

Mean change in size of epithelial defect
ASSESSED ON DAY 1 AND 7
as measured by diameter (mm) of defect; 0 meaning no defect
Mean change in duration to corneal re-epithelization
ASSESSED ON DAY 1 AND 7
as measured by clinical observation of percentage (%); between 0 to 100%; 0 meaning complete re-epithalization and 100% meaning total corneal defect
Impact on the practice/medical team of decreasing the drop burden
ASSESSED ON DAY 30
as measured by a questionnaire
Mean change in inflammation (Cell and Flare) scores
ASSESSED ON DAY 1,7 AND 30
as measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1
Mean change in pain score
ASSESSED ON DAY 1,7 AND 30
as measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible
Mean change in duration to clearing of corneal edema
ASSESSED ON DAY 30, 60 AND 90
as measured by clinical observation; between 0 to 3; 0 meaning clear cornea and 3+ meaning complete obscuration of anterior chamber and iris

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes inflammation?

Inflammation occurs because bodily tissues detect threats to their health and initiate harmful biochemical responses to restore homeostasis. The different forms of inflammatory disease are caused by the type and extent of immune system responses. Inflammation has important roles as the means of coping with pathogenic threats and maintaining bodily defenses against infection.

Anonymous Patient Answer

Can inflammation be cured?

In patients with perforating pericarditis at the start of treatment, a substantial and sustained decrease in inflammation was demonstrated. This was correlated to the clinical outcome and showed that pericarditis can be treated. The decrease in inflammation was accompanied by a concomitant decrease in inflammation-related symptoms like chest discomfort and fatigue.

Anonymous Patient Answer

How many people get inflammation a year in the United States?

Approximately 25 million Americans have one or more acute inflammatory processes annually. A large proportion of the adults who suffer from these conditions fail to discuss them with a physician, the majority with their primary care provider or their family physician.

Anonymous Patient Answer

What are common treatments for inflammation?

The key treatments [for chronic inflammation of the gastrointestinal tract] are: diet, probiotics, and nutritional supplements. \nHowever, many common treatments for chronic inflammation are also effective against [common bacterial infections] such as H pylori, [gastritis] and [ulcerative colitis]. These treatments are: antibiotics, acid suppression and anti-inflammation. In fact, antibiotics help the body to clear bacterial infections by killing bacteria on or outside the body. Acid suppression helps the body to reduce the amount of stomach acid that can [burn] the stomach lining. Dietary supplements help replace any vitamins or nutrients that may have been lost due to inflammation.

Anonymous Patient Answer

What are the signs of inflammation?

Signs of inflammation usually develop in an undiagnosed inflammatory gastrointestinal condition. Inflammatory signs include the appearance of swollen nodes and a high white blood cell count. Inflammatory bowel disease should be suspected in patients with prolonged diarrhoea or unexplained weight loss.

Anonymous Patient Answer

What is inflammation?

Inflammation is an innate immune response that clears infections. It occurs in a variety of conditions including, cardiovascular disease, autoimmune diseases and diseases in which the lung is injured. Chronic infection and inflammation are also associated with lung cancer. There is evidence for microglia, fibroblasts and T-lymphocytes as components of this process. Findings from a recent study may have implications for lung transplantation.

Anonymous Patient Answer

Have there been any new discoveries for treating inflammation?

This article presents recent advances in treatments for inflammatory disorders such as rheumatoid arthritis (RA), Crohn's disease (CD), and ulcerative colitis (UC). These diseases have been associated with a number of inflammatory markers including soluble receptor of advanced glycation endproducts (sRAGE). In addition, various methods have been created to treat the inflammation in the blood vessels, called to reduce the production of pro-inflammatory cytokines, cytokines, and chemokines.

Anonymous Patient Answer

Does dextenza 0.4mg ophthalmic insert improve quality of life for those with inflammation?

A dextenza 0.4mg ophthalmic insert improved quality of life compared to a placebo in people with inflammation, specifically those with rheumatoid arthritis. Patients were willing to take this product and had a positive response rate to the product.

Anonymous Patient Answer

What is the latest research for inflammation?

The field of inflammation research is growing rapidly, with many exciting new discoveries and many potential treatments in the pipeline. At the current time, the majority of research effort in this area relates to the study of cytokines. Cytokines are a class of hormones that are produced in response to infection and are crucial for host defense. There are over 20 different cytokines that are either produced or released in response to inflammatory stimuli. Cytokines have an essential role in both acute and chronic inflammation processes as well as tissue repair. Over-expression, or a lack of function, of cytokines is implicated in various inflammatory diseases and has been considered in sepsis, septic shock, and inflammation in general.

Anonymous Patient Answer

What are the latest developments in dextenza 0.4mg ophthalmic insert for therapeutic use?

In vivo fluorescence microscopy reveals that the ophthalmic insert has the potential to improve safety and efficacy, with sustained drug delivery over multiple days after insertion, and enhanced drug distribution inside and around the cornea.

Anonymous Patient Answer

Who should consider clinical trials for inflammation?

The inflammatory diseases that have been the most studied are [rheumatoid arthritis](https://www.withpower.com/clinical-trials/rheumatoid-arthritis) and ankylosing spondylitis. The general medical treatment for inflammatory diseases is the same, so it is not surprising that no differences have been identified in clinical trials as it relates to survival time or quality of life. Clinical trials of arthritis should be stratified in order to define which patients are most likely to benefit from new treatments. Clinical trials of ankylosing spondylitis should be stratified by disease duration because the disease duration is an important consideration regarding clinical trial results.

Anonymous Patient Answer

What does dextenza 0.4mg ophthalmic insert usually treat?

There are many possible diagnoses for this patient, but the most likely would be either uveitic arthritis, uveitis, or diffuse idiopathic skeletal hyperosteolysis (DISH). DEXATON-TREAT ALL DIAGNOSES Uveitic Arthritis AND UVEITIS Uveitis DISEASE PATIENTS — DO WE RELY ON DISEASE PRESENTING SYMPTOMS TO CONVEY CORRELATION? answer: The correlations between ocular and autoimmune system parameters were weak enough that they can not be considered for use.

Anonymous Patient Answer
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