A Study for Comparing a Generic Combination of Brinzolamide and Timolol Eye Drops versus Azarga® Eye Drops in the Treatment of Patients with Glaucoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

OmniVision GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

15 Jul 2024 → 21 May 2025

Decision date (initial)

2024-05-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To confirm the clinical non-inferiority of a new generic fixed combination of Brinzolamide 10mg/ml + Timolol 5mg/ml eye drops compared to the reference product Azarga® 10mg/ml + 5mg/ml eye drops, in patients with elevated intraocular pressure (open angle glaucoma or ocular hypertension) by examining the average change of diurnal intraocular pressure (IOP) from end of study to baseline and comparing between the two study arms.

Secondary objectives 1

1. To compare the overall efficacy and safety of the two combined brinzolamide / timolol products (test and reference) in subjects with ocular hypertension or open angle glaucoma.

Conditions and MedDRA coding

Ocular Hypertension

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. male or female, of any race and ≥18 years of age
2. diagnosed of unilateral or bilateral open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension; either on treatment or treatment naïve
3. able to safely discontinue use of all ocular hypotensive medication(s) and undergo appropriate washout period
4. best-corrected visual acuity ≥20 of 100 corresponding to logMAR ≤ 0.7 in both eyes
5. females who participate in the study are either unable to gestate [i.e. post-menopausal (absence of menses for 12 months prior to drug administration), hysterectomy, bilateral oophorectomy, tubal ligation at least 6 months prior to drug administration] or at reproductive age; Females of reproductive age if sexually active, must be practicing an effective method of birth control throughout the study; reliable contraception methods are considered the following: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal; progestogen-only hormonal contraception associated with inhibition of ovulation oral, implantable or injectable; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence
6. expected by the investigator that IOP will remain controlled under treatment without optic nerve damage or progression of visual field loss
7. able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits
8. willing to provide voluntarily written informed consent and data protection declaration before any clinical trial related procedure is performed

Exclusion criteria 30

1. history of chronic or recurrent inflammatory eye disease (i.e. scleritis, uveitis, herpes keratitis), ocular trauma within the past 6 months or ocular inflammation within the past 3 months or infections
2. any uncontrolled systemic disease
3. narrow-angle/angle-closure glaucoma
4. compromised cornea or corneal abnormalities that will preclude accurate IOP-reading with an applanation tonometer
5. clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment) in either eye
6. intraocular surgery within the past 3 months
7. ocular laser surgery within the past 1 month
8. planned ocular surgery of any kind during study participation
9. extremely narrow or partially closed angle, cup/disk ratio >0.8
10. severe central visual field loss (i.e., sensitivity ≤10 decibel [dB] in at least 2 of the 4 visual field test points closest to the point of fixation) in either eye
11. treatment with local or systemic corticosteroids in non-stable doses in the last 30 days
12. treatment with oral carbonic anhydrase inhibitors (e.g., acetazolamide, methazolamide, topiramate, sultiame, zonisamide)
13. any change in any systemic medication that could affect IOP within the last 30 days before the beginning of and during the study (e.g., clonidine, β-blockers etc.)
14. a history of, or current severe hepatic or renal impairment
15. a history of, or current hyperchloraemic acidosis
16. known hypersensitivity to sulphonamides
17. known hypersensitivity to beta-blockers
18. history of allergic hypersensitivity or poor tolerance to any component of the eye drops used in this clinical trial
19. a history of, or current other severe ocular pathology (including severe dry eye) in either eye, that would preclude the administration of a topical carbonic anhydrase inhibitor (CAI) or beta-blocker
20. current reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
21. severe allergic rhinitis
22. sinus bradycardia, sick sinus syndrome, sino-atrial block, second- or third-degree atrioventricular block not controlled with pace-maker
23. overt cardiac failure, cardiogenic shock
24. pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control
25. current participation or not yet completed period of at least 30 days since ending of another investigational device or drug trial(s)
26. unwillingness or inability to comply with the clinical trial procedures
27. severe illness or other condition that would make the patient, in the opinion of the Investigator, unsuitable for the study
28. unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons
29. who are legally incapacitated
30. who are legally detained in an official institute

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary efficacy endpoint will be the difference between Test and Reference products in mean diurnal IOP change from baseline to week 12 visit after adjusting for baseline measurement (week 0)

Secondary endpoints 3

1. Difference between Test and Reference products in mean diurnal IOP change from baseline to week 2 visit after adjusting for baseline measurement (week 0)
2. Difference between Test and Reference products in mean diurnal IOP change from baseline to week 6 visit after adjusting for baseline measurement (week 0)
3. Frequency of study drugs’ related adverse events

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

OmniVision GmbH

Sponsor organisation

OmniVision GmbH

Address

Lindberghstrasse 9, Puchheim-Bahnhof Puchheim-Bahnhof

City

Puchheim

Postcode

82178

Country

Germany

Scientific contact point

Organisation

OmniVision GmbH

Contact name

Dr. Tobias Kohl

Public contact point

Organisation

OmniVision GmbH

Contact name

Dr. Tobias Kohl

Third parties 1

Locations

1 EU/EEA country · 14 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 10 files

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

Application history

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