Study on Clobetasol Propionate and Prednisolone Acetate for Treating Eye Inflammation After Cataract Surgery in Children Aged 0-3 Years

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What is this study about?

This clinical trial is focused on studying the treatment of inflammation and pain that can occur after cataract surgery in young children aged 0 to 3 years. The study compares two different eye drop treatments: Clobetasol propionate ophthalmic nanoemulsion, 0.05% and Prednisolone acetate ophthalmic suspension, 1%. The purpose of the study is to assess the safety of these treatments in managing inflammation after surgery.

Participants in the study will receive one of the two treatments after their cataract surgery. The study will monitor the children over a period of several weeks to observe any changes in their condition. The study will include regular check-ups to assess the level of inflammation in the eye and to ensure the safety of the treatments. The study aims to determine which treatment is more effective in reducing inflammation and pain following the surgery.

Throughout the study, the children will be closely observed for any side effects or changes in their eye condition. The study will also track any changes in the pressure inside the eye and overall eye health. The results will help doctors understand which treatment is safer and more effective for young children who have undergone cataract surgery.

1 initial visit and consent

The patient, aged 0 to 3 years, is enrolled in the study after undergoing routine cataract surgery in one eye. The caregiver provides signed informed consent.

The patient must show clinical evidence of postoperative inflammation in the eye.

2 randomization and treatment initiation

The patient is randomly assigned to receive either Clobetasol propionate ophthalmic nanoemulsion, 0.05%, or Prednisolone acetate ophthalmic suspension, 1%.

Both medications are administered as eye drops. The specific dosage and frequency are determined by the study protocol.

3 follow-up visit 1

Visit 1 occurs on Day 1, where the patient’s eye condition is assessed, including inflammation grade and intraocular pressure.

The caregiver is instructed to continue administering the assigned eye drops as per the study protocol.

4 follow-up visit 2

Visit 2 is scheduled for Day 8, with a possible variation of plus or minus 2 days.

The patient’s eye is examined for changes in inflammation and other parameters. The caregiver continues the treatment as instructed.

5 follow-up visit 3

Visit 3 takes place on Day 15, with a possible variation of plus or minus 2 days.

The patient’s progress is monitored, focusing on inflammation and any adverse effects. Treatment continues as per the protocol.

6 follow-up visit 4

Visit 4 is conducted on Day 29, with a possible variation of plus or minus 2 days.

The study team evaluates the patient’s response to the treatment, including inflammation levels and any side effects.

7 final follow-up visit

Visit 5 occurs on Day 43, with a possible variation of plus or minus 3 days.

The final assessment includes a comprehensive evaluation of the patient’s eye condition, focusing on inflammation and overall eye health.

Who Can Join the Study?

The child must be a boy or girl aged 0 to 3 years old, meaning they have not yet turned 4 years old.
The child should be a candidate for routine, uncomplicated cataract surgery in one eye. This surgery may or may not include placing a lens inside the eye.
The child’s caregiver(s) must be able and willing to follow all treatment and follow-up procedures.
The parents or legally authorized representative(s) of the child must sign an informed consent form, which is a document that explains the study and confirms their agreement to participate.
The child must have already undergone routine, uncomplicated cataract surgery in one eye, with or without a lens placed inside the eye.
The child must show clinical signs of inflammation after surgery. This means there is noticeable swelling or irritation inside the front part of the eye.

Who Cannot Join the Study?

Patients who have any other eye conditions that could affect the study results.
Patients who have had any other eye surgery recently.
Patients who are allergic to any of the study medications.
Patients who are taking other medications that might interfere with the study.
Patients who have any serious health conditions that could affect their participation.
Patients who are unable to follow the study instructions.
Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Provincial De Conxo	Santiago De Compostela	Spain
Hospital Universitario De Cruces	Barakaldo	Spain
Fycjhjsfn Pffb Lm Ipzrbidwbmkva Bnnlhnihj Dlk Hqxmsjqg Uvweejvlsadjm Lw Ppu	Madrid	Spain
Hebfuvza Uwlafhdistnuz Hzkcdltz Tfbck y Pzksdg Idquoxvh Cnegqo dwtnqwevowtzypqaq (twzw	Badalona	Spain
Hxxhaygn Vgps djtkzgvv	Barcelona	Spain
Hlptvosd Uqtyoxoracyrn dv A Cczltu	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.11.2022

Trial locations

Investigated drugs:

Clobetasol propionate is being tested in this trial as an eye drop in the form of a nanoemulsion. It is used to reduce inflammation after cataract surgery in young children aged 0 to 3 years. The goal is to see if it is safe and effective for this purpose.

Prednisolone acetate is another eye drop used in this trial. It is a suspension that helps reduce inflammation after cataract surgery. It is being compared to Clobetasol propionate to determine which is more effective and safe for treating inflammation in young children who have had cataract surgery.

Investigated diseases:

Inflammation and pain associated with ocular surgery – This condition occurs when the eye becomes inflamed and painful following surgical procedures, such as cataract surgery. The inflammation is typically due to the body’s immune response to the surgical intervention. Symptoms may include redness, swelling, and discomfort in the eye. The condition can affect vision temporarily and may cause sensitivity to light. It usually progresses as the body heals from the surgery, with symptoms gradually decreasing over time. Management of this condition often involves monitoring and addressing the inflammation to ensure proper healing.

Trial ID:

2024-513489-20-00

Protocol code:

CLOBOF3-17IA03

NCT ID:

NCT05724446

Trial Phase:

Therapeutic confirmatory (Phase III)

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