International study on RD03/2016 eye drops compared to Leviosa® eye drops for the prevention and treatment of inflammation and the prevention of infections associated with cataract surgery in adults – FAST 7

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Ntc S.r.l.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Decision date (initial)

2026-07-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To demonstrate the non-inferior efficacy of RD03/2016 vs. Leviosa® for 7 days in the prevention and treatment of postoperative ocular inflammation.

Secondary objectives 4

1. To describe conjunctival hyperemia at Day 8.
2. To describe ocular pain/discomfort at Day 8.
3. To describe the use of rescue therapy during treatment.
4. To describe the incidence of endophthalmitis.

Conditions and MedDRA coding

Cataract

Study design 4 periods

Regulatory references

Scientific advice from competent authorities

Swedish Medical Products Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Signed written informed consent must be obtained before any assessment is performed.
2. Male or female, age ≥40 years.
3. Scheduled senile or presenile cataract surgery (not yet performed).
4. Willing to interrupt the use of contact lenses for the entire duration of the study.
5. Able and willing to follow study procedures.
6. For females of childbearing potential, the use of highly effective contraception and agreement to use such a method during study participation.
7. Cataract surgery completed without complications.

Exclusion criteria 12

1. Ocular conditions that at the discretion of the Investigator may interfere with the efficacy and/or safety evaluations (e.g. ocular herpes, blepharitis, conjunctivitis, uveitis, keratitis, diabetic retinopathy, retinal vein occlusions, retinal vasculitis, retinal angiomatous proliferation, pseudo-exfoliation syndrome, intraoperative floppy iris syndrome, etc.).
2. Patients undergoing bilateral cataract surgery.
3. Patients under treatment with prostaglandin analogues or intravitreal injections of anti-VEGF (vascular endothelial growth factor) drugs.
4. Systemic diseases that may interfere with the results of the study (e.g. rheumatoid arthritis, Sjögren's syndrome, Behçet's disease, systemic lupus erythematosus, scleroderma with major ocular involvement, etc.).
5. Any condition that could interfere with the correct instillation of eye drops.
6. Ocular surgery in the study eye (including laser surgery) in the 3 months before screening.
7. Monocular patients.
8. Visual Acuity < 20/80 of the contralateral eye measured as ETDRS or Snellen 20 feet, equal to 0.25 in decimal.
9. Contraindication to ocular treatment with ketorolac, dexamethasone or levofloxacin as follows: - Herpes simplex keratitis, vaccinia, varicella and other viral diseases of the cornea and conjunctiva - Fungal and mycobacterial diseases of ocular structures or untreated parasitic eye infections - Uncontrolled intraocular hypertension - Uncontrolled glaucoma - Untreated purulent infections of the eye - Acute, untreated bacterial infections
10. Hypersensitivity to the products or their excipients.
11. Participation in previous clinical studies if less than 5 half-lives of the IMPs used have not elapsed
12. Pregnancy or breastfeeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of patients with «absence of signs of anterior chamber inflammation (cells and flare)» after 7 days of treatment (Day 8).

Secondary endpoints 4

1. Proportion of patients with conjunctival hyperemia at Day 8.
2. Proportion of patients with ocular pain/discomfort at Day 8.
3. Proportion of patient using rescue therapy during treatment.
4. Proportion of patients with onset endophthalmitis at Day 8.

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ntc S.r.l.

Sponsor organisation

Ntc S.r.l.

Address

Via Luigi Razza 3

City

Milan

Postcode

20124

Country

Italy

Scientific contact point

Organisation

Ntc S.r.l.

Contact name

Alessandro Colombo

Public contact point

Organisation

Ntc S.r.l.

Contact name

Alessandro Colombo

Third parties 3

Locations

2 EU/EEA countries · 3 investigational sites

By country

Investigational sites

Results and documents

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

Documents 33 files

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

Application history

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