Cataracts InfantilePhase 3CLOSE-3NCT05724446
Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population
A Phase 3 study testing Clobetasol Propionate and Prednisolone acetate ophthalmic suspension, 1% in people with Cataracts Infantile, run by Salvat at 1 site in Spain.
Trial summary
Multicenter, randomized, evaluator-blinded clinical trial compared to Prednisolone acetate, 1% in the treatment of inflammation and pain after cataract surgery in pediatric population. Read more about this study
- Who is it for?
- Ages 0 months to 3 years
- Conditions the study is for
- Cataracts Infantile
- What is being tested?
- Clobetasol Propionate and Prednisolone acetate ophthalmic suspension, 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2022to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female, aged 0 to 3 years old (have not had their 4th birthday) on the day of consent.
- Patients who are candidate for routine, uncomplicated cataract surgery in one eye with or without intraocular lens.
- Patients whose caregiver(s) is/are able and willing to comply with all treatment and follow-up procedures.
- Signed informed consent from (ICF) parents or patient's legally authorized representative(s).
- Patients who have undergone routine, uncomplicated cataract surgery in one eye with or without intraocular lens.
- Patients with clinical evidence of postoperative inflammation (anterior chamber inflammation grade > 0).
Who cannot join
- Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
- Active uveitis in the study eye.
- Ocular neoplasia in the study eye.
- Post-traumatic cataract in the study eye.
- Suspected permanent low vision or blindness in the fellow non-study eye. The study eye must not be the patient's only good eye.
- Use of any topical medication in the study eye within 2 days prior to surgery, except for those required for ocular examination or preoperative preparation.
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- Systemic administration of any steroidal anti inflammatory drugs in the previous 2 weeks prior to the surgery.
- Systemic administration of any non-steroidal anti inflammatory drugs in the previous 48 hours prior to the surgery.
- Patient or patient's breastfeeding mother who is expected to use corticosteroids (except corticosteroid inhalers and dermatological corticosteroids, as long as they are not used on the eyelids or surrounding area, and oral prednisolone steaglate drops as part of the standard treatment after cataract surgery) or immunosuppressants during the 30 days following cataract surgery.
- History of steroid-induced increase in IOP in either eye.
- Patients with glaucoma, ocular hypertension, or those receiving IOP lowering therapy in either eye or systemically.
- Any current corneal abrasion or ulceration.
- Known or suspected allergy or hypersensitivity to similar drugs, such as other corticosteroids, or their components.
- Patients who have had ocular surgery in the study eye within 90 days prior to surgery.
- History of post-operative unresolved inflammation in the contralateral eye.
- Presence or history of chronic generalized systemic disease that the Investigator believes may either increase the risk to the subject or confound the results of the study (e.g., Diabetes mellitus, human immunodeficiency virus [HIV], acquired immunodeficiency syndrome [AIDS]).
- Any concurrent process which, in the opinion of the investigator, could impair patients' safety or limit adherence to the study protocol.
- Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study.
- Prior participation in the study described in this protocol unless the patient wasn't randomized.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospìtal Sant Joan de Deu
Barcelona, 08950
Marta Morales, MD
About this study
Official title: A Phase 3, Multicenter, Randomized, Evaluator-blinded Clinical Trial to Assess the Safety and Efficacy of Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% Compared to Prednisolone Acetate, 1% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population 0 to 3 Years of Age (CLOSE-3)
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.
- Conditions
- Cataracts Infantile
- Being tested
- Clobetasol Propionate, Prednisolone acetate ophthalmic suspension, 1%
- Keywords
- Cataract surgery, Inflammation, Pain
- Medical subject headings
- Inflammation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clobetasol PropionateDrug
Also called SVT-15473
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).
Prednisolone acetate ophthalmic suspension, 1%Drug
Microfine sterile ophthalmic suspension of dense and whitish appearance.
| Study group | Role | What they receive |
|---|---|---|
| Clobetasol propionate | Experimental | 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. Receives: Drug: Clobetasol Propionate |
| Prednisolone acetate | Active comparator | 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. Receives: Drug: Prednisolone acetate ophthalmic suspension, 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 43
Secondary outcomes (2)
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.
- = Mild: Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal.
- = Moderate: Moderate anterior chamber clouding.
- = Severe: Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished.
- = Very severe: Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished.
Measured: 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.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start12 Dec 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataracts InfantileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salvat
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724446
- Sponsor's protocol ID
- CLOBOF3-17IA03
- Acronym
- CLOSE-3
- Status last verified
- Sep 2024
- First submitted
- 23 Jan 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Evaluator-blinded Clinical Trial to Assess the Safety and Efficacy of Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% Compared to Prednisolone Acetate, 1% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population 0 to 3 Years of Age (CLOSE-3)
- ClinicalTrials.gov ID
- NCT05724446
- Acronym / sponsor ID
- CLOSE-3 / CLOBOF3-17IA03
- Conditions
- Cataracts Infantile
- Keywords
- Cataract surgery, Inflammation, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SalvatIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clobetasol propionate | Experimental | Drug: Clobetasol PropionateOne 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. |
| Prednisolone acetate | Active comparator | Drug: Prednisolone acetate ophthalmic suspension, 1%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. |
Who may qualify
- Ages
- 0 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female, aged 0 to 3 years old (have not had their 4th birthday) on the day of consent.
- Patients who are candidate for routine, uncomplicated cataract surgery in one eye with or without intraocular lens.
- Patients whose caregiver(s) is/are able and willing to comply with all treatment and follow-up procedures.
- Signed informed consent from (ICF) parents or patient's legally authorized representative(s).
- Patients who have undergone routine, uncomplicated cataract surgery in one eye with or without intraocular lens.
Key exclusion criteria (19 listed)
- Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
- Active uveitis in the study eye.
- Ocular neoplasia in the study eye.
- Post-traumatic cataract in the study eye.
- Suspected permanent low vision or blindness in the fellow non-study eye. The study eye must not be the patient's only good eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clobetasol PropionateAlso: SVT-15473Clobetasol 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). | Drug | Clobetasol propionate |
| Prednisolone acetate ophthalmic suspension, 1%Microfine sterile ophthalmic suspension of dense and whitish appearance. | Drug | Prednisolone acetate |
Primary outcome
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%.
Time frame: Day 43
Number, frequency, severity, and relationship to IMP of adverse events (AEs) up to last study visit.
2 secondary outcomes
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%.
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%.
Time frame: Day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clobetasol Propionate and Prednisolone acetate ophthalmic suspension, 1% in people with Cataracts Infantile, run by Salvat at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrique Jimenez (+34 933946400, ejimenez@svt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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%. (time frame: Day 43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.