To determine effifacy and safety of generic brinzolamide ophthalmic suspension compared with AZOPT ® in subjects with open-angle glaucoma or ocular hypertension.
- Conditions
- Health Condition 1: - Health Condition 2: H401- Open-angle glaucoma
- Registration Number
- CTRI/2021/05/033515
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd SPI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Male or nonpregnant females aged 18 years or older with chronic open-angle glaucoma or ocular
hypertension in both eyes.
-Provide signed and dated informed consent in accordance with good clinical practice (GCP) and
local legislation prior to any study procedure.
-Be able and willing to follow study instructions and complete all required visits.
-Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive
medication(s) or switch ocular hypotensive medications and undergo an appropriate washout
period.
-Adequate wash-out period prior to the baseline of any ocular hypotensive medication
Subjects with angle closure glaucoma
- Females who are pregnant, breast feeding, or planning a pregnancy.
- Females of childbearing potential who do not agree to utilize an adequate
form of contraception.
- Current, or past history of, severe hepatic or renal impairment
- Current, or history within 2 months prior to the baseline of, significant
ocular disease
- Current corneal abnormalities that would prevent accurate IOP
readings with the Goldmann applanation tonometer.
- Functionally significant visual field loss
- Corneal thickness >600 um
- Contraindication to brinzolamide or sulfonamide therapy or
known hypersensitivity to any component of brinzolamide or
sulfonamide therapy
- Use at any time prior to baseline of an intraocular
corticosteroid implant.
- Use within 1 week prior to the baseline of contact lens
- Having undergone within 12 months prior to baseline
refractive surgery, filtering surgery, or laser surgery for
IOP reduction.
- Subjects currently in another clinical trial
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method