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Comparing the effectiveness of nepafenac and dexamethasone sodium phosphate for treating eye inflammation after cataract surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Postoperative inflammation after cataract surgery, which is redness, swelling, or irritation in the eye that can occur after an operation to remove a cloudy lens. The goal of the study is to compare a combination of two medications in one dropper against using each medication separately to see which helps reduce eye inflammation more quickly. The medications being studied include a combination of dexamethasone sodium phosphate and nepafenac, while the individual components used for comparison are nepafenac and dexamethasone phosphate. Additionally, tobramycin may be used as a background treatment.

During the study, participants will use different types of eye drops. The research will monitor several aspects of eye health, such as conjunctival hyperaemia, which is an increase in blood flow that makes the white part of the eye look red, and ocular pain or discomfort. The study also looks at central macular thickness, which refers to the thickness of the part of the retina responsible for sharp, central vision, using a specialized imaging method called optical coherence tomography. Other factors monitored include intraocular pressure, which is the fluid pressure inside the eye, and best corrected visual acuity, which is the clearest vision possible with the help of glasses or contact lenses.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Background medication
During the study, tobramycin eye drops (an antibiotic used to prevent infection) must be used by applying 6 drops into the eye.
Step 2
Study medication administration
One of three different eye drop treatments will be used to manage inflammation (redness or swelling) after cataract surgery (a procedure to clear the lens of the eye).
The treatment assigned will be one of the following:
A combination of dexamethasone sodium phosphate and nepafenac, applied as 3 drops.
Nepafenac alone, applied as 3 drops.
Dexamethasone phosphate alone, applied as 3 drops.
Step 3
Monitoring and evaluation
The eye will be examined on day 1, 3, 5, 7, 14, and 30 after the surgery to check for inflammation in the front part of the eye.
Evaluations will be conducted to monitor eye pressure, vision clarity, and any eye redness.
On day 30, an optical coherence tomography (a specialized type of eye imaging) will be performed to measure the thickness of the central part of the retina (the light-sensitive layer at the back of the eye).
Step 4
Symptom reporting
On day 1, 3, 5, 7, and 14, any eye pain, discomfort, burning, stinging, or blurred vision must be noted.
General eye symptoms will also be monitored during these specific days.

Who can join the trial?

10 criteria

You must provide signed written informed consent, which means you have read and agreed to participate in the study after being told all the details.
You must be male or female and be 40 years of age or older.
You must be scheduled for a routine unilateral cataract surgery, which is a standard operation to remove a cloudy lens in one eye.
The surgery must involve phacoemulsification, a method that uses sound waves to break up the cloudy lens, and posterior chamber intraocular lens implantation, which is the placement of an artificial lens inside the eye.
You may have cataracts in both eyes, but only if you are scheduled to have surgery on just one eye.
You must be willing to stop wearing contact lenses for the entire length of the study.
You must be able and willing to follow all the rules and steps required by the study.
Women who are still able to have children must have a negative urine pregnancy test before receiving the study medicine.
Women who can have children must use or agree to use a highly effective method of contraception (a way to prevent pregnancy, such as an IUD or specific hormonal methods) throughout the study and for a period after the study ends.
The surgery must be completed without complications (unexpected medical problems) that would make it difficult to follow the study or interfere with the results.

Who cannot join the trial?

16 criteria

Eye conditions that might interfere with how well the treatment works or how safe it is, such as uveitis (swelling inside the eye), diabetic retinopathy (eye damage caused by diabetes), retinal vasculitis (swelling of the blood vessels in the back of the eye), pseudo-exfoliation syndrome (a condition that causes flaky material to build up in the eye), intra-operative floppy iris syndrome (a condition where the iris muscle does not react normally during surgery), or any sign of intraocular inflammation (swelling or redness inside the eye) before surgery.
A known hypersensitivity (an allergic reaction) to any part of the study medicines, the medicines used during the procedure, salicylates, or other NSAIDs (medicines used to reduce pain and swelling).
Active or uncontrolled eye infections, such as viral infections (caused by viruses) of the cornea (the clear front part of the eye) or conjunctiva (the thin layer covering the white of the eye), fungal infections, bacterial infections, or amoebic keratitis (an infection caused by tiny organisms).
A perforation (a hole), ulceration (a sore), or injury to the cornea where the surface layer has not fully healed.
A history of corticosteroid-induced intraocular hypertension (high pressure inside the eye caused by steroid medications).
Taking part in another clinical study within the last month or before the study medicine from a previous study has completely left your system.
Being pregnant or breastfeeding during the entire study period.
Having bilateral cataract surgery (surgery on both eyes) at the same time.
Having any eye surgery, including laser surgery, in the eye being studied within the 3 months before the screening process.
Using prostaglandin analogues (eye drops used to lower eye pressure) or receiving intravitreal injections (injections directly into the jelly-like substance of the eye) of anti-VEGF drugs (medicines used to stop abnormal blood vessel growth) within 3 months before surgery or having them scheduled shortly after surgery.
Using NSAIDs (pain and swelling medicines) in eye drops, through breathing, or by mouth within 1 week of surgery.
Using corticosteroids (steroid medicines) in eye drops, through breathing, or by mouth within 15 days of surgery, or receiving steroid injections near the eye within 3 months of surgery.
Having any other illnesses in the body that might affect how wounds heal or how swelling goes down after surgery.
Any condition that makes it difficult to properly use the prescribed eye drops.
Being monocular (having vision in only one eye).
Having vision in the other eye that is worse than 20/80 on a standard eye chart, which means seeing at 20 feet what a person with normal vision sees at 80 feet.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
A.O.U. Policlinico G. Martino Di Messina
Messina, Italy
Verified
ARNAS Garibaldi Di Catania
Catania, Italy
Responsive
Azienda Ospedaliero-Universitaria Sant Andre
Rome, Italy

Trial locations

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Investigated drugs

Nepafenac
is an eye drop used to reduce inflammation and swelling in the eye.
Dexamethasone sodium phosphate
and nepafenac are used together in a single eye drop solution to provide a combination of treatments to reduce inflammation in the eye after surgery.
Dexamethasone phosphate
is an eye drop used to treat inflammation in the eye.
Tobramycin
is an eye drop used as an antibiotic to treat bacterial infections in the eye.

What is already known about the treatment

Nepafenac
This medication is administered as eye drops applied directly into the eye to treat inflammation. It is a well-established non-steroidal anti-inflammatory drug used to reduce swelling and pain, such as after eye surgery. At a molecular level, it works by blocking specific enzymes that produce chemicals responsible for triggering inflammation in the body.
Dexamethasone sodium phosphate
This substance is used as eye drops to manage swelling and redness in the eye. It is a widely recognized steroid medication used to treat various inflammatory eye conditions. It works by calming the body's immune response and blocking the production of many different chemicals that cause inflammation.
Dexamethasone phosphate
This medication is applied to the eye using liquid drops to reduce inflammation. It is a commonly used steroid that helps treat swelling and irritation in many medical situations. It acts by interfering with the cellular processes that lead to the development of inflammation and swelling.
Tobramycin
This medication is administered as eye drops to treat bacterial infections of the eye. It is a standard antibiotic used to kill harmful bacteria that cause ocular infections. It works by stopping the bacteria from producing the proteins they need to grow and multiply.

Investigated diseases

Postoperative inflammation after cataract surgery - This condition involves swelling and irritation inside the eye following a surgical procedure to remove a cloudy lens. It typically manifests as an increase in inflammatory cells or protein within the anterior chamber of the eye. The reaction may also cause redness in the white part of the eye and general discomfort. As the process progresses, it can lead to changes in the thickness of the central retina or fluctuations in eye pressure. The inflammation usually develops shortly after the surgery and may last for several days or weeks.