A Phase 3 interventional study of Clobetasol Propionate and Prednisolone acetate ophthalmic suspension, 1% in Cataracts Infantile, sponsored by Salvat. Recruiting at 1 site in Spain. Open to participants aged 0 Months to 3 Years. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Salvat · Phase 3, Interventional, and Treatment
Multicenter, randomized, evaluator-blinded clinical trial compared to Prednisolone acetate, 1% in the treatment of inflammation and pain after cataract surgery in pediatric population. This study will assess the safety of Clobetasol propionate ophthalmic nanoemulsion, 0.05% to that of Prednisolone acetate, 1% when administering one drop four times a day (QID) for 14 days followed by a tapering period of 14 days after cataract surgery.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →Salvat is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Compared within Inflammation, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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The human immunodeficiency virus, which weakens the immune system.
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A drug or device being studied in a clinical trial.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One drop of Clobetasol propionate ophthalmic nanoemulsion, 0.05% will be administered of the study eye QID beginning the day after surgery (Day 1) for 14 days followed by a tapering period of 14 days.
Drug: Clobetasol Propionate
One drop of Prednisolone ophthalmic suspension, 1% will be administered of the study eye QID beginning the day after surgery (Day 1) for 14 days followed by a tapering period of 14 days.
Drug: Prednisolone acetate ophthalmic suspension, 1%
Clobetasol propionate ophthalmic nanoemulsion 0.05 % is an oil-in-water (O/W), clear or slightly yellowish nanoemulsion containing the active ingredient clobetasol propionate at a concentration of 0.05% weight per weight (w/w).
Also known as: SVT-15473
Microfine sterile ophthalmic suspension of dense and whitish appearance.
Assess the safety of Clobetasol propionate ophthalmic nanoemulsion, 0.05% treatment after cataract surgery in pediatric population 0 to 3 years of age, compared to Prednisolone acetate ophthalmic suspension, 1%.
Number, frequency, severity, and relationship to IMP of adverse events (AEs) up to last study visit.
Time frame: Day 43
Assess the efficacy on ocular inflammation of Clobetasol propionate ophthalmic nanoemulsion, 0.05% treatment after cataract surgery in pediatric population 0 to 3 years of age, compared to Prednisolone acetate ophthalmic suspension, 1%.
Percentage of patients with anterior chamber inflammation of grade 0. Anterior chamber inflammation is graded on a 5-point scale: 0 = None: Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal. 1. = Mild: Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal. 2. = Moderate: Moderate anterior chamber clouding. 3. = Severe: Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished. 4. = Very severe: Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished.
Time frame: Day 15
Assess the efficacy on pain of Clobetasol propionate ophthalmic nanoemulsion, 0.05% treatment after cataract surgery in pediatric population 0 to 3 years of age, compared to Prednisolone acetate ophthalmic suspension, 1%.
Change in the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale Score. Higher scores mean a worse outcome. Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten.
Time frame: Day 15
Started Dec 2022 (actual). Primary completion is estimated for Dec 2025, 36 months after the start.
Of 21 industry-sponsored phase 3 interventional studies under Inflammation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 28. This study's planned 36 months is above that.
Counting every sponsor, half of 68 studies reached it within 27 months; a quarter within 17 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Clobetasol
Salvat