Glaucoma, Open-Angle
Conditions
Brief summary
This is a randomized, double-masked, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. Test Product - Bimatoprost Ophthalmic Solution, 0.01% of Mankind Pharma Limited, India Reference Product - LUMIGAN® (Bimatoprost Ophthalmic Solution) 0.01% of Allergan, Inc.,
Detailed description
Subjects with chronic open-angle glaucoma or ocular hypertension in both the eyes and meeting all the mentioned inclusion criteria and none of the exclusion criteria will be identified. Qualifying Intra Ocular Pressure (IOPs) following wash-out, at baseline (Day 0 at anytime of the day) should be ≥ 22 milli meter mercury (mm Hg) and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg. Subjects will receive one drop of investigational product (either A or B) in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days. The study subjects will undergo clinical evaluations throughout the study in order to assess efficacy and safety. Study subject primary endpoint evaluation will be assessed after 2 weeks (day 14) and 6 weeks ( Day 42) of treatment for each study subject deemed eligible for evaluation. The primary bioequivalence comparison is between the test and reference products for the mean difference in intraocular pressure (IOP) of both eyes between the two treatment groups at six time points, i.e., at 00.00 hours (between 8:00am and 10:00 am), 04.00 hours (at 4 hours after 00.00 hours) and 08.00 hours ( at 8 hours after 00.00 hours) on Day 14 (week 2) and Day 42 (week 6) visits.
Interventions
Subjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days.
Subjects in the second arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days.
Sponsors
CBCC Global Research
Mankind Pharma Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects willing and able to provide voluntary informed consent and to follow the protocol requirements 2. Male or non-pregnant females aged ≥18 years having body mass index (BMI) ≥ 17 calculated as weight in kg/height in m2. 3. Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. 4. Subjects requiring treatment of both the eyes and can discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo an appropriate washout period 5. Adequate wash-out period prior to baseline of any ocular hypotensive medication as per the table below (In order 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 subjects must have discontinued all ocular hypotensive medications for the minimum washout period 6. Baseline (Day 0/hour 0) IOP ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and difference in IOP between the eyes is not greater than 5 mm Hg 7. Subject's IOP is likely to be controlled with monotherapy as per the discretion of the investigator 8. Baseline best-corrected visual acuity equivalent to 20/200 (6/60) or better in each eye 9. Women of child-bearing potential (defined as women physiologically capable of becoming pregnant, unless they are using an effective contraception method during dosing of the investigational product) practicing any two acceptable contraception methods Acceptable methods of contraception are: 1. Oral or parenteral (injection) , patch, or implant) hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication 2. Intrauterine device (IUD) or intrauterine system IUS) 3. A double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent) 4. Male sterilization (at least six months prior to the screening, should be the sole male partner for that subject) 5. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least six weeks prior to study participation 6. Total abstinence, partial abstinence is not acceptable 10. No history of addiction to any recreational drug or drug dependence or alcohol addiction
Exclusion criteria
1. Hypersensitivity to Bimatoprost or related class of drugs or any of the excipients of the formulation 2. Severe hepatic or renal impairment 3. Current or history within two months prior to the baseline of any other significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye. Note: - Stable myopia, strabismus and cataracts (as per investigator's discretion) will be allowed provided other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Six Time Points | Day 14 and 42 at 00.00 hours (between 8:00 AM and 10:00 AM), 04.00 hours (at 4 hours after 00.00 hours), and 08.00 hours (at 8 hours after 00.00 hours) | Change in mean difference in intraocular pressure (IOP) of both the eyes between the two treatment groups at six time points, i.e., at 00.00 hours (between 8:00 am and 10:00 am), 04.00 hours (at 4 hours after 00.00 hours), and 08.00 hours (at 8 hours after 00.00 hours) on Day 14 (week 2) and Day 42 (week 6) visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and efficacy of Bimatoprost 0.01% Ophthalmic Solution | Safety will be evaluated throughout the study (6 weeks) and telephonic safety follow-up on day 49±3 days | To monitor the adverse events and safety of the subjects and tolerability of Bimatoprost 0.01% Ophthalmic Solution |
Countries
United States
Outcome results
None listed