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).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Laboratorios Salvat S.A.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

21 Nov 2022 → ongoing

Decision date (initial)

2024-06-27

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513489-20-00

EudraCT number

2022-000624-37

ClinicalTrials.gov

NCT05724446

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To 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%.

Secondary objectives 2

1. To 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%, as determined by the changes in the anterior chamber inflammation and changes in other signs and symptoms of ocular inflammation.
2. To 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%, as determined by the changes in the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale Score.

Conditions and MedDRA coding

Inflammation and pain associated with ocular surgery

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male or female, aged 0 to 3 years old (have not had their 4th birthday) on the day of consent.
2. Patients who are candidate for routine, uncomplicated cataract surgery in one eye with or without intraocular lens.
3. Patients whose caregiver(s) is/are able and willing to comply with all treatment and follow-up procedures
4. Signed informed consent from (ICF) parents or patient's legally authorized representative(s).
5. Patients who have undergone routine, uncomplicated cataract surgery in one eye with or without intraocular lens.
6. Patients with clinical evidence of postoperative inflammation (anterior chamber inflammation grade > 0).

Exclusion criteria 19

1. Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
2. Active uveitis in the study eye
3. Ocular neoplasia in the study eye
4. Post-traumatic cataract in the study eye
5. Suspected permanent low vision or blindness in the fellow non-study eye. The study eye must not be the patient's only good eye
6. 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
7. Systemic administration of any steroidal anti inflammatory drugs in the previous 2 weeks prior to the surgery, except for those required for preoperative preparation.
8. Systemic administration of any non-steroidal anti inflammatory drugs in the previous 48 hours prior to the surgery, except for those required for preoperative preparation
9. 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
10. History of steroid-induced increase in IOP in either eye
11. Patients with glaucoma, ocular hypertension, or those receiving IOP lowering therapy in either eye or systemically
12. Any current corneal abrasion or ulceration
13. Known or suspected allergy or hypersensitivity to similar drugs, such as other corticosteroids, or their components
14. Patients who have had ocular surgery in the study eye within 90 days prior to surgery
15. History of post-operative unresolved inflammation in the contralateral eye
16. 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]).
17. Any concurrent process which, in the opinion of the investigator, could impair patients' safety or limit adherence to the study protocol
18. 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
19. Prior participation in the study described in this protocol unless the patient wasn't randomized

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

1. Number, frequency, severity and relationship to IMP of adverse events (AEs) up to last study visit
2. Number, frequency, severity and relationship to IMP of Serious AE (SAEs) up to last study visit
3. Proportion of patients discontinuing the study due to AEs
4. Proportion of patients discontinuing the study due to lack of efficacy
5. Change from baseline to each study visit in intraocular pressure (IOP)
6. Change from baseline to each study visit in visual acuity and physical and eye examination parameters

Secondary endpoints 5

1. Percentage of patients with anterior chamber inflammation of grade 0 at Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3).
2. Change from baseline to Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3) in the proportion of patients with different grades of anterior chamber inflammation
3. Proportion of patients with Grade 1, Grade 2, Grade 3 and Grade 4 of anterior chamber inflammation at Visit 1 (Day 1), Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3).
4. Frequency of different signs and symptoms of ocular inflammation at baseline, Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3).
5. Change from baseline to Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3) in the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale Score

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratorios Salvat S.A.

Sponsor organisation

Laboratorios Salvat S.A.

Address

Calle Gall 30 36, Poligono Industrial Esplugues De Llobregat Poligono Industrial Esplugues De Llobregat

City

Esplugues De Llobregat

Postcode

08950

Country

Spain

Scientific contact point

Organisation

Laboratorios Salvat S.A.

Contact name

Enrique Jiménez

Public contact point

Organisation

Laboratorios Salvat S.A.

Contact name

Enrique Jiménez

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications