Randomized, Open Label, Parallel-Group, Two-Arm, Multicenter Study with Clinical Endpoint Comparing Preservative Free Bimatoprost Ophthalmic Solution 0.1 Mg/Ml and Lumigan® (Bimatoprost Ophthalmic Solution) 0.1 Mg/Ml in Patients with Chronic Open-Angle Glaucoma or Ocular Hypertension in One or Both Eyes.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Genetic S.p.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

5 Apr 2024 → 3 Mar 2026

Decision date (initial)

2024-02-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-504759-28-00

WHO UTN

U1111-1290-1262

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the efficacy, tolerability, and safety of Bimatoprost 0.1 mg/ml unit dose formulation compared to the reference Lumigan® in patients with Chronic Open Angle Glaucoma or Ocular Hypertension.

Conditions and MedDRA coding

Ocular Hypertension

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients willing and able to provide voluntary informed consent and to follow protocol requirements.
2. Male or females aged ≥18 years
3. Patients with chronic open-angle glaucoma or ocular hypertension in one or both eyes.
4. Patients can switch ocular hypotensive medications and undergo appropriate washout period, under clinical Investigator’s discretion.
5. At Baseline IOP > 21 mm Hg and ≤ 35 mm Hg in one or both eyes.
6. At Baseline best corrected visual acuity (BCVA) equivalent to Snellen acuity of 20/200 or better in each eye.

Exclusion criteria 24

1. Female patient: pregnant, lactating or planning pregnancy within next 12 months (Female of child-bearing potential will undergo urine pregnancy test).
2. Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study.
3. Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
4. Current or history of severe hepatic or renal impairment.
5. Current or history within 2 months prior to baseline of any other significant ocular disease (e.g., corneal oedema, uveitis, ocular infection, or ocular trauma in either eye (Note: stable myopia, strabismus, and cataracts as per the Investigator's discretion will be allowed provided that the other inclusion/exclusion criteria are met).
6. Current corneal abnormalities that would prevent accurate IOP readings with Goldmann applanation tonometer.
7. Significant visual field defect (MD>15.0 dB)
8. Patients with corneal grafts.
9. Use at any time prior to baseline of an intraocular corticosteroid implant.
10. Use of contact lens within 1 week prior to baseline.
11. Use within 2 weeks prior to baseline of a topical ophthalmic corticosteroid.
12. Use within 1 month prior to baseline of a systemic corticosteroid.
13. Use within 6 months prior to baseline of intravitreal or subtenon injection of an ophthalmic corticosteroid.
14. Underwent within 6 months prior to baseline any other intraocular surgery (e.g., cataract surgery).
15. Underwent within 12 months prior to baseline any refractive surgery, filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty).
16. Patients with a history of IOP previously uncontrolled and stabilized on Bimatoprost monotherapy
17. Significant ocular surface findings (e.g., hyperaemia or irritation, moderate or greater) in either eye found on slit lamp examination.
18. Retinopathy
19. Chronic use of any systemic medication that may affect IOP with less than 3 months stable dosing regimen (i.e., sympathomimetic agents, beta-adrenergic blocking agents, alpha-agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.)
20. Central Corneal thickness (CCT) <450 microns or >650 microns.
21. Known history or presence of any uncontrolled systemic disease (e.g., cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment, etc.)
22. History of recurrent ocular seasonal allergies within the past 2 years.
23. Any other medical condition or serious intercurrent illness that, in the Investigator's opinion, may make it undesirable for the patient to participate in the study and would limit adherence to the study requirements.
24. Participation in any clinical study within 90 days before the first dose of the study treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Difference in intraocular pressure (IOP) of one eye, (if both eyes have been treated only the contralateral right eye will be chosen) between the two treatment groups of the mean percentage reduction from baseline (V2) to day 42 (V5).

Secondary endpoints 3

1. Efficacy: Reduction in IOP, at each follow-up time point, as compared with baseline, in the two study groups.
2. Tolerability: Local tolerability assessed through Ocular Surface Disease Index (OSDI), Efron scale, Oxford scale, from baseline (V2) to day 42 (V5).
3. Safety: Quantitative and Qualitative Evaluation of Safety in terms of adverse events reported.

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Genetic S.p.A.

Sponsor organisation

Genetic S.p.A.

Address

Via Giuseppe Della Monica 26

City

Castel San Giorgio

Postcode

84083

Country

Italy

Scientific contact point

Organisation

Genetic S.p.A.

Contact name

Rocco Carmelo Pavese

Public contact point

Organisation

Genetic S.p.A.

Contact name

Rocco Carmelo Pavese

Third parties 1

Locations

1 EU/EEA country · 6 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 9 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