Health Condition 1: H401- Open-angle glaucoma
Conditions
Interventions
Intervention1: Test Product 1 (T1) - Bimatoprost ophthalmic solution: Bimatoprost ophthalmic solution 0.01%
Dose: One drop
Frequency: Once daily
Route of Administration: Ophthalmic route
Duration of t
Sponsors
Kashiv BioSciences Pvt Ltd
COD Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent. 2. Able and willing to comply with the protocol, including availability for all scheduled study visits. 3. Male and Female patients aged >= 18 years along with having either ocular hypertension or chronic open-angle glaucoma in both eyes 4. Patient requires bilateral IOP lowering therapy and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period 5. Patientâ??s IOP likely to be controlled with monotherapy as per the sole discretion of the investigator 6. Adequate wash-out period prior to baseline of any IOP lowering medication 7. Baseline best-corrected visual acuity score equivalent to Snellen acuity of 20/100 or better in each eye 8. Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing any two acceptable methods of contraception. 9. Female patients with negative urine pregnancy test at baseline (only for female who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation). 10. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to Bimatoprost or related class of drugs or to any of the excipients of the formulation. 2. Current history of any other significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye which in opinion of the investigator would interfere with the interpretation of the study data. Note: - Stable myopia, strabismus and cataracts (as per investigatorâ??s sole discretion) will be allowed provided other inclusion/exclusion criteria meet 3. Functionally significant visual field loss as per the sole discretion of the investigator or evidence of progressive visual field loss within the last year 4. Use at any time prior to baseline of an intraocular corticosteroid implant. 5. Use within three weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid or 3). Oral or injectable steroids 6. Patient with corneal grafts 7. Patient has contraindication to pupil dilation 8. History of severe ocular trauma or history of laser, intraocular, or filtering surgery within 3 months prior to baseline, or refractive surgery at any time 9. Amblyopia - only one sighted eye 10. Allergy or contraindication to the use of fluorescein 11. Recent (within previous 2 months) or anticipated alteration of existing chronic systemic treatment or introduction of treatment with agents which could have a substantial effect on IOP (including, but not necessarily limited to, systemic adrenergic agents including beta-adrenergic blocking agents, e.g., propranolol, metoprolol, nadolol, timolol, and atenolol), substantial interactions with study medications, or interaction with study outcomes as per the sole discretion of the investigator. 12. History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment etc.) 13. History of recurrent ocular seasonal allergies within the past 2 years 14. Patient with past history of IOP previously uncontrolled on bimatoprost monotherapy 15. Patient has condition or is in a situation which, in the investigatorâ??s opinion, may have put the patient at a significant risk, may have confounded study results, or may have interfered significantly with the patientâ??s participation in the study 16. Participation in any other clinical or device study within 30 days before the first dose of Investigational Product 17. Pregnant or Lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in average IOP of both eyesTimepoint: Day 0, Day 43 | — |
Secondary
| Measure | Time frame |
|---|---|
| Diurnal IOPTimepoint: Day 0, Day 43;Mean Change from baseline IOP at Day 43Timepoint: Day 0, Day 43 | — |
Countries
India
Contacts
Public ContactDr Prayag N Shah
Kashiv BioSciences Pvt. Ltd
Outcome results
None listed