2023-506494-35-00
Completed
Phase 3
A Therapeutic Non-Inferiority, Randomized, Observer-blind, Active-reference, Two-arm, Parallel Group, Multi-center Clinical Trial for Comparing the Efficacy and Tolerability of a Generic Fixed Combination of Brinzolamide 10mg/ml + Timolol 5mg/ml Eye Drops versus Azarga® 10mg/ml + 5mg/ml Eye Drops in the Treatment of Intraocular Pressure in Patients with Open Angle Glaucoma or Ocular Hypertension
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- OmniVision GmbH
- Enrollment
- 234
- Locations
- 13
- Primary Endpoint
- 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)
Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •male or female, of any race and ≥18 years of age
- •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
- •able to safely discontinue use of all ocular hypotensive medication(s) and undergo appropriate washout period
- •best-corrected visual acuity ≥20 of 100 corresponding to logMAR ≤ 0.7 in both eyes
- •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
- •expected by the investigator that IOP will remain controlled under treatment without optic nerve damage or progression of visual field loss
- •able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits
- •willing to provide voluntarily written informed consent and data protection declaration before any clinical trial related procedure is performed
Exclusion Criteria
- •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
- •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
- •treatment with local or systemic corticosteroids in non-stable doses in the last 30 days
- •treatment with oral carbonic anhydrase inhibitors (e.g., acetazolamide, methazolamide, topiramate, sultiame, zonisamide)
- •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.)
- •a history of, or current severe hepatic or renal impairment
- •a history of, or current hyperchloraemic acidosis
- •known hypersensitivity to sulphonamides
- •known hypersensitivity to beta-blockers
- •history of allergic hypersensitivity or poor tolerance to any component of the eye drops used in this clinical trial
Outcomes
Primary Outcomes
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)
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 Outcomes
- Difference between Test and Reference products in mean diurnal IOP change from baseline to week 2 visit after adjusting for baseline measurement (week 0)
- Difference between Test and Reference products in mean diurnal IOP change from baseline to week 6 visit after adjusting for baseline measurement (week 0)
- Frequency of study drugs’ related adverse events
Investigators
Dr. Tobias Kohl
Scientific
OmniVision GmbH
Study Sites (13)
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