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About
A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study
Full description
Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes who meet all of the inclusion criteria and none of the exclusion criteria will be identified.
Potential subjects will be screened within 6 weeks prior to administration of the first drop of study drug. They will undergo a washout period of 4 days to 4 weeks (28 days) based on their current medication (if available). Based on stratification criteria, IOP and CCT information available at baseline visit for each subject, the subjects will be randomized in such way that ratio of treatment distribution will be nearer to 1:1 between the treatment arms, and within the combined stratification criteria. The Primary Endpoint is mean difference in the IOP of both eyes between the two treatment groups at 3 time points, i.e., at 00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at Day 14 (Week 2) (± 4 days) and Day 42 (Week 6) (± 4 days) visits.
The Secondary Endpoint: the incidence of all adverse events reported during the study will be summarized by treatment group. Test and reference products will be compared for safety by analyzing nature, severity and frequency of treatment emergent adverse events.
Enrollment
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Inclusion criteria
Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.
Male or females aged ≥18 years.
Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes
Subjects requiring treatment of both eyes and able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
Adequate washout period prior to baseline of any ocular hypotensive medications as (to minimize potential risk to subjects due to intraocular pressure (IOP) elevations during the washout period, the Investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergic blocking agent, or prostaglandin; however, all the subjects must have discontinued their ocular hypotensive medications for the minimum washout period .
Baseline (Day 0/hour 0) IOP ≥22 mm Hg and <28 mm Hg in each eye, with difference between the IOP in left and right eyes not being more than 5 mm Hg
Subjects' IOP is likely to be controlled with monotherapy as per the Investigator's discretion.
Baseline best corrected visual acuity equivalent to Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart for testing at 10 feet (3 meters).
Women of childbearing potential (defined as women physiologically capable of becoming pregnant unless they are using an effective method of contraception during the dosing of the study drug) practicing any of the following acceptable methods of contraception:
No history of addiction to any recreational drug or drug dependence or alcohol addiction
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
240 participants in 2 patient groups
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Central trial contact
Ilesh Changela, MD
Data sourced from clinicaltrials.gov
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