Health Condition 1: - Health Condition 2: H401- Open-angle glaucoma
Conditions
Interventions
Intervention1: SPILs Brinzolamide ophthalmic suspension USP 1% w/v
: dose: one drop of study medication
frequency: three times a day
route of administration: Topical ocular administration
duration of therapy: 6 weeks
Control Intervention1: AZOPT®: dose: one drop of study medication
duration of therapy: 6 weeks
Sponsors
Sun Pharmaceutical Industries Ltd SPIL
Eligibility
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in IOP of both eyes between the two treatment groupsTimepoint: Baseline, Week 2 & Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in IOP of both eyes between the 2 treatment groups.Timepoint: approximately 8:00 AM. (hour 0; before the morning drop) and 10:00 AM. (hour 2) at the Day 14 (Week 2) and Day 42 (Week 6) visits. | — |
Countries
India, Russian Federation
Contacts
Public ContactDr Hany Michail
Sun Pharma Advanced Research Limited
Outcome results
None listed