A Study for Comparing a Generic Combination of Brimonidine and Timolol Eye Drops versus Combigan® 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]

Decision date (initial)

2026-03-27

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, Efficacy, Safety

To confirm the clinical non-inferiority of a new generic fixed dose combination of Brimonidine Tartrate 2 mg/ml + Timolol 5 mg/ml eye drops, phosphate free, preservative-free, compared to the comparator product Combigan® 2 mg/ml + 5 mg/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 in order to compare the two study arms.

Secondary objectives 1

1. To compare the overall efficacy and safety of the two combined brimonidine tartrate / timolol products (Test and Comparator) 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 10

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
3. average IOP ≥ 22 mm Hg and ≤ 34 mm Hg measured at 08:00 am, 12:00 am and 04:00 pm pre-treatment at baseline in at least one eye
4. without treatment for open-angle glaucoma with IOP-lowering drugs, for at least 4 weeks
5. best-corrected visual acuity ≥20 of 100 (Snellen) corresponding to logMAR ≤ 0.7 in the study eye
6. 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
7. expected by the investigator that IOP will remain controlled under treatment without optic nerve damage or progression of visual field loss
8. patients with controlled arterial blood pressure according to the investigator’s opinion
9. able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits
10. willing to provide voluntarily written informed consent and data protection declaration before any clinical trial related procedure is performed

Exclusion criteria 36

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. 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
3. treatment with local or systemic corticosteroids in non-stable doses in the last 30 days
4. treatment with oral carbonic anhydrase inhibitors (e.g., acetazolamide, methazolamide, topiramate, sultiame, zonisamide)
5. ocular treatment with any prostamide, prostaglandin, carbonic anhydrase inhibitor and pilocarpine
6. current use of topical, ocular, nonsteroidal anti-inflammatory drugs
7. 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.)
8. known hypersensitivity to beta-blockers
9. a history of allergic hypersensitivity or poor tolerance to any component of the eye drops used in this clinical trial
10. a history of, or current other severe ocular pathology (including severe dry eye) in either eye, that would preclude the administration of a beta-blocker
11. a history of depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans
12. any uncontrolled systemic disease
13. current reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
14. severe acute allergic rhinitis
15. sinus bradycardia, sick sinus syndrome, sino-atrial block, second- or third-degree atrioventricular block not controlled with pace-maker
16. overt cardiac failure, cardiogenic shock
17. use at any time prior to baseline of intraocular corticosteroid implant
18. use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid
19. use within one month prior to baseline of: 1) systemic corticosteroid, 2) monoamine oxidase (MAO) inhibitor therapy, 3) any antidepressant which affects noradrenergic transmission (e.g., tricylic antidepressants, mianserin) or 4) adrenergic-augmenting psychotropic drug (e.g., desipramine, amitriptyline)
20. use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid
21. underwent within twelve months prior to baseline: refractive surgery, filtering surgery or laser surgery for IOP reduction
22. pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control
23. narrow-angle/angle-closure glaucoma
24. current participation or not yet completed period of at least 30 days since ending of another investigational device or drug trial(s)
25. unwillingness or inability to comply with the clinical trial procedures
26. severe illness or other condition that would make the patient, in the opinion of the Investigator, unsuitable for the study
27. unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons
28. who are legally incapacitated
29. who are legally detained in an official institute
30. compromised cornea or corneal abnormalities that will preclude accurate IOP-reading with an applanation tonometer
31. clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment) in either eye
32. intraocular surgery within the past 3 months
33. ocular laser surgery within the past 1 month
34. planned ocular surgery of any kind during study participation
35. extremely narrow or partially closed angle, cup/disk ratio >0.8
36. a history of, or current severe hepatic or renal impairment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary efficacy endpoint will be the difference between Test and Comparator 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 Comparator in mean diurnal IOP change from baseline to week 2 visit after adjusting for baseline measurement (week 0).
2. Difference between Test and Comparator 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 · 13 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 10 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