Ongoing Clinical Trials for Eye Inflammation
There are currently 2 ongoing clinical trials investigating treatments for eye inflammation. These trials are exploring different steroid medications and their effectiveness in managing inflammation following eye surgery and in patients with ocular prostheses. The trials are being conducted in Spain and France.
Clinical trial locations
- France
- Spain
Study on Clobetasol Propionate and Prednisolone Acetate for Treating Eye Inflammation After Cataract Surgery in Children Aged 0-3 Years
This trial is investigating treatments for inflammation that occurs after cataract surgery in very young children. The study compares two different eye drop medications to determine which is safer and more effective for managing post-surgical inflammation in children aged 0 to 3 years.
Who can participate:
Children must be between 0 and 3 years old and scheduled for routine, uncomplicated cataract surgery in one eye. The surgery may or may not include placement of a lens inside the eye. After the surgery, the child must show clinical signs of inflammation in the front part of the eye. Parents or legal guardians must be able to follow all treatment instructions and visit schedules, and they must sign an informed consent form agreeing to their child’s participation.
Who cannot participate:
Children are excluded if they have other eye conditions that could affect the study results, have recently had other eye surgery, are allergic to the study medications, are taking other medications that might interfere with the study, have serious health conditions that could affect participation, are unable to follow study instructions, or are already participating in another clinical trial.
What the trial is studying:
The trial focuses on assessing the safety of two different steroid eye drop treatments in managing inflammation after cataract surgery. Children are randomly assigned to receive either Clobetasol propionate ophthalmic nanoemulsion or Prednisolone acetate ophthalmic suspension. Over several weeks, researchers monitor inflammation levels, eye pressure, and overall eye health through regular check-ups on Days 1, 8, 15, 29, and 43. The study aims to determine which treatment is safer and more effective in reducing inflammation and pain following surgery.
Investigational drugs:
Clobetasol propionate is being tested as an eye drop in nanoemulsion form. It works by inhibiting the release of substances that cause inflammation. Prednisolone acetate is administered as an eye drop suspension and works by suppressing the immune response that leads to inflammation. Both medications are corticosteroids, a type of anti-inflammatory medication commonly used to reduce swelling and discomfort in the eyes.
Comparison of hydrocortisone and dexamethasone eye drops for treating inflammatory conjunctival secretions in patients with ocular prostheses
This study examines treatments for inflammation and discharge that occur in the eye socket of patients who wear artificial eyes. The trial compares three different eye drop solutions to determine which is most effective in managing secretions and reducing inflammation.
Who can participate:
Adults aged 18 years or older who have been wearing an eye prosthesis for more than 6 months can participate. They must have a Modified OSDI score of 13 or higher, which indicates a certain level of eye discomfort symptoms. Participants must be registered with a health insurance scheme, able to provide written informed consent, and under the care of an eye specialist department. Both men and women can participate.
Who cannot participate:
The study excludes people under 18, those with known allergies to any of the study medications, patients with active eye infections such as bacterial or viral conjunctivitis, those currently participating in other clinical trials, patients who have had eye surgery within the last 3 months, individuals with uncontrolled systemic diseases like diabetes or high blood pressure, pregnant or breastfeeding women, patients using other eye medications that could interfere with the study, individuals who cannot follow the protocol or attend scheduled visits, and people with severe dry eye syndrome requiring additional treatments.
What the trial is studying:
The trial evaluates how well two different anti-inflammatory steroid medications work compared to artificial tears in managing secretions in patients with eye prostheses. Participants are randomly assigned to receive one of three eye drop solutions: Dexafree containing dexamethasone, Softacort containing hydrocortisone, or Dulcilarmes containing povidone as an artificial tear substitute. Treatment lasts for 14 days. Researchers monitor changes in the amount, color, and consistency of eye secretions, as well as the level of inflammation in the eye socket tissue. The study also tracks how these treatments affect participants’ daily comfort and quality of life.
Investigational drugs:
Hydrocortisone is a topical steroid eye medication that reduces inflammation by suppressing the immune system’s response in the eye socket. Dexamethasone is a more potent steroid that also reduces inflammation and is commonly used for various inflammatory eye conditions. Both medications work at the molecular level by blocking the production of inflammatory chemicals. Dulcilarmes is an artificial tear solution that provides lubrication and moisture to the eye socket and prosthesis, serving as a comparison treatment to evaluate the effectiveness of the steroid medications.
Summary
The two ongoing clinical trials for eye inflammation represent different approaches to managing inflammation in distinct patient populations. One trial focuses on very young children aged 0 to 3 years following cataract surgery, while the other addresses inflammation in adults who wear ocular prostheses. Both trials are investigating steroid-based treatments, comparing different corticosteroid medications to determine the most effective and safe options.
The trials are geographically distributed, with one taking place in Spain and the other in France. A notable observation is that both studies emphasize the safety and effectiveness of topical steroid treatments, reflecting the continued importance of corticosteroids in managing eye inflammation. The Spanish trial is particularly noteworthy for focusing on a vulnerable population of very young children, highlighting the need for specialized research in pediatric ophthalmology. The French trial addresses a specific quality-of-life issue for people living with ocular prostheses, an area that may receive less attention in clinical research but significantly impacts daily life for affected individuals.
