A multicenter clinical trial for the comparison of efficacy and safety in the treatment of elevated intraocular pressure in adult patients with glaucoma.
- Conditions
- Open-angle glaucoma,
- Registration Number
- CTRI/2023/06/054478
- Lead Sponsor
- AZAD Pharma AG
- Brief Summary
This will be “ A multicenter, randomized, assessor-blinded, activecontrolled, parallel group, two arm, non-inferiority clinical trial for the comparisonof efficacy and safety of Brinzolamide 10mg/ml & Brimonidine tartrate 2mg/ml eye drops suspension (AZAD Pharma AG, Switzerland) and Simbrinza® (Brinzolamide 10 mg/ml & Brimonidine tartrate 2 mg/ml) eye dropssuspension (Novartis Europharm Limited, Ireland ) in the treatment of elevatedintraocular pressure in adult patients with open-angle glaucoma or ocularhypertension.
Blinding will be performed using identical boxes in primary packaging in thetwo groups, and in the replacement of the commercial labels for the comparator (reference product) in thebottles. An unblinded independent site personnel will dispense theinvestigational medicinal products, collect used and unused products and administer the treatment tothe patient at the clinic after the IOP measurement and these site personnel will not participate inthe clinical trial assessments (including IOP measurements)in order to minimize potential bias, and will be instructed not to discussabout the study drugs withIOP assessors, and other study personnel.
Each study patient will self-administer one drop of test or referenceproduct in the study eye. The patient may also administer in non-study eye asper investigators suggestion (if needed). Eye drop will be instilled in lowerconjunctival sac, two times daily, at approximately 09:00 a.m. (±30 minutes)and 09:00 p.m. (±30 minutes) for 12 weeks. During study visits, designatedunblinded independent site personnel will administered the 9 a.m. dose afterIOP measurement.
On the day of efficacy assessment (Visit 4, Visit 5 and Visit 6),when the study treatment is to be administered at the site, evaluators will not be in the roomwhenever the IMP is taken out of the external packagingor the patient is dosed with a IMP.
Dosing at site will be done by unblinded independent site personnel, trained in IP administration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 208
- Male and female patients, aged 18-75 years (both inclusive), diagnosed with bilateral or unilateral open-angle glaucoma or ocular hypertension, who in the opinion of the Investigator, were insufficiently controlled on monotherapy or were already on multiple IOP lowering medications.
- Mean IOP measurements in at least one eye (the same eye), must have been: ▪ ≥ 24 mmHg and ≤ 36 mmHg at the 9 a.m. time point, and ▪ ≥ 21 mmHg and ≤ 36 mmHg at the 11 a.m. time point at both the Eligibility 1 and Eligibility 2 visits following washout of any IOP-lowering medication.
- â–ª Mean IOP must not have been > 36 mmHg in either eye at any time point.
- Adequate wash-out period prior to baseline of any ocular hypotensive medication.
- Patients must have provided IEC approved written informed consent using the latest version of the IEC informed consent form.
- Patients must be in good health and free from any clinically significant disease apart from indication under study.
- Patients able to comply with study procedures in the opinion of the investigator.
- Study patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required scheduled study visits.
- Patients must be able to safely discontinue use of all ocular hypotensive medication(s) and undergo appropriate washout period.
- Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration).
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- Pregnant or lactating females. 2. Chronic, recurrent or severe inflammatory eye disease. 3. Severe central visual field loss (i.e., sensitivity ≤10 dB in ≥2 of the 4 visual field test points closest to the point of fixation) in either eye. 4. Schaffer angle grade <2 degree in either eye (as measured by gonioscopy). 5. Cup-to-disc ratio >0.80 (horizontal or vertical measurement) in either eye. 6. Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent). 7. Unable to safely discontinue IOP-lowering ocular medications per the washout schedule. 8. Current or history within 3 months prior to baseline of significant ocular disease, e.g., corneal edema, uveitis, ocular infection, ocular inflammation, corneal ulcerin either eye or corneal foreign body. 9. Ocular trauma within the preceding 6 months. 10. Contraindication to brimonidine tartrate, brinzolamide or sulfonamide therapy or known hypersensitivity to sulfonides or any component of brimonidine tartrate and brinzolamide ophthalmic suspension. 11. Use of intraocular corticosteroid implant at any time prior to baseline. 12. Use of contact lens within one week prior to baseline. 13. Ocular laser surgery within the 3 months prior to entry. 14. Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid. 15. Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose (more than 1 g daily) salicylate therapy 3) monoamine oxidase(MAO) inhibitor therapy, 4) any antidepressant which affects noradrenergic transmission (e.g. tricyclic antidepressants, mianserin) or 5) adrenergic–augmenting psychotropic drug (e.g. desipramine, amitriptyline). 16. Use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid. 17. Underwent within six months prior to baseline any other intraocular surgery (e.g., cataract surgery). 18. Underwent within 12 months prior to baseline: refractive surgery, filtering surgery for IOP reduction. 19. Amblyopia.
- only one sighted eye. 20. Clinically significant or progressive retinal disease (e.g., retinal degeneration, diabetic retinopathy, retinal detachment) in either eye. 21. Any abnormality preventing reliable applanation tonometry. 22. History or presence of significant alcoholism or drug abuse in the past one year. 23. Active smoker at the time of screening. 24. Active or prior severe, unstable, or uncontrolled cardiovascular, cerebrovascular, hepatic, or renal disease that would prevent safe administration of topical a-adrenergic agonists or carbonic anhydrase inhibitors, according to the investigator. 25. Any form of glaucoma other than open-angle glaucoma. 26. Therapy with an investigational agent within the past 30 days from screening. 27. Clinically significant hematologic and/or biochemical abnormalities based on laboratory testing as judged by investigator. 28. Patients who are at risk of visual field or visual acuity worsening as a consequence of participation of trial as per Investigator discretion. 29. Any other conditions, including severe illness, which would make the patient, in the opinion of the Investigator, unsuitable for the study. 30. Chronic use of any systemic medication that may affect IOP with less than three-month 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.). 31. Use of any prescribed medication during last two weeks or OTC medicinal products during the last one week preceding the first dosing that is affecting the IOP or result in drug-drug interaction with the study drug. 32. Major illness, as per investigator discretion, during 3 months before screening. 33. Participating in a clinical study within the past 3 months. 34. Pupil with inadequate ability to dilate sufficiently for peripheral retinal examination. 35. Patients with risk of angle closure or evidence of acute, intermittent or chronic angle closure. 36. History or evidence of severe inflammatory eye disease (i.e. uveitis, retinitis, scleritis) in one or both eyes. 37. Patients with severe allergic rhinitis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint is mean change from baseline to week 12 in diurnal IOP [the average • Screening | • Visit 2 – Eligibility Visit (At the end of the washout period for patients who already had received IOP lowering medications) | • Visit 3 (3-8 days after eligibility (Visit 2)) | • Visit4 –Follow up Visit(week 2) | • Visit5 –Follow up Visit(week 6) | • Visit6 –End of study(week 12) of the IOP measured at 9 a.m. and 11 a.m. time points] of study eye in the test arm as compared to • Screening | • Visit 2 – Eligibility Visit (At the end of the washout period for patients who already had received IOP lowering medications) | • Visit 3 (3-8 days after eligibility (Visit 2)) | • Visit4 –Follow up Visit(week 2) | • Visit5 –Follow up Visit(week 6) | • Visit6 –End of study(week 12) reference arm. • Screening | • Visit 2 – Eligibility Visit (At the end of the washout period for patients who already had received IOP lowering medications) | • Visit 3 (3-8 days after eligibility (Visit 2)) | • Visit4 –Follow up Visit(week 2) | • Visit5 –Follow up Visit(week 6) | • Visit6 –End of study(week 12)
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability profile of the test product and reference product. • Mean change from baseline to Week 2 and Week 6 in diurnal IOP [the average of the IOP measured at 9 a.m. & 11 a.m-assessment time points] of study eye in the test arm as compared to reference arm using ANCOVA.
Trial Locations
- Locations (14)
Ambade Eye Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Dr. Agrawals eye clinic
🇮🇳Ahmadabad, GUJARAT, India
Eye care Super specialty Hospital
🇮🇳Ahmadabad, GUJARAT, India
Insight Institute of Opthalmology
🇮🇳Pune, MAHARASHTRA, India
Jyoti Eye Hospital
🇮🇳Ahmadabad, GUJARAT, India
Kanoria Hospital Research Centre
🇮🇳Gandhinagar, GUJARAT, India
King George’s Medical University
🇮🇳Lucknow, UTTAR PRADESH, India
Munadada ENT & Eye Care center
🇮🇳Aurangabad, MAHARASHTRA, India
Nandadeep Eye Hospital
🇮🇳Sangli, MAHARASHTRA, India
Netralaya Super Speciality Eye Hospital
🇮🇳Ahmadabad, GUJARAT, India
Scroll for more (4 remaining)Ambade Eye Hospital🇮🇳Nagpur, MAHARASHTRA, IndiaDr Ajay AmbadePrincipal investigator9823178466dr_ajayambade@rediffmail.com