BE study with clinical endpoint comparing generic bimatoprost ophthalmic solution 0.01% and LUMIGAN® (bimatoprost ophthalmic solution) 0.01% in the treatment of subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.
- Conditions
- Health Condition 1: H401- Open-angle glaucoma
- Registration Number
- CTRI/2024/02/062212
- Lead Sponsor
- Dr. Ilesh Changela
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.
2. Male or females aged greater than or equal to18 years.
3. Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes
4. Subjects requiring treatment of both eyes and able to discontinue the use of all ocular hypotensive medications or switch ocular hypotensive medications and undergo appropriate washout period.
5. Adequate washout period prior to baseline of any ocular hypotensive medications as per the table below (to minimize potential risk to subjects due to intraocular pressure 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 provided in the table below).
Parasympathomimetics (eg. pilocarpine, carbachol)4 days
Carbonic anhydrase inhibitors (systemic or topical) (eg. acetazolamide, dorzolamide hydrochloride, brinzolamide)4 days
Sympathomimetics (eg. dipivefrin, epinephrine)2 weeks
Alpha-agonists (eg. apraclonidine, brimonidine tartrate, brimonidine tartrate and brinzolamide combination)2 weeks
Beta-adrenergic blocking agents (eg. timolol, timolol maleate and dorzolamide hydrochloride combination, timolol maleate and brimonidine tartrate combination, levobunolol, betaxolol, metipranolol, carteolol)4 weeks
Prostaglandin analogs (eg. latanoprost, travoprost, bimatoprost, tafluprost)4 weeks
Osmotic agents
(eg. Mannitol, Isosorbide, Glycerin)4 days
Rho kinase inhibitors (eg. Ripasudil, Netarsudil)4 weeks
7. Subjects IOP is likely to be controlled with monotherapy as per the Investigators discretion.
8. Baseline best corrected visual acuity equivalent to Snellen acuity of 20 by 100 or better in each eye, using a logarithmic visual acuity chart for testing at 10 feet (3 meters).
9. 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:
a. Oral or parenteral (injection, patch, or implant) hormonal contraception which has been continuously used for at least 1 month prior to first dose of study medication.
b. Intrauterine device or intrauterine system
c. Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent)
d. Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject)
e. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
f. Total abstinence, partial abstinence is not acceptable
10. No history of addiction to any recreational drug or drug dependence or alcohol addiction
1. Female who are pregnant, lactating or planning a pregnancy.
2. Subjects recently diagnosed with open-angle glaucoma or ocular hypertension and who are treatment naive.
3. Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
4. Current or history of severe hepatic or renal impairment.
5. Current or history within 2 months prior to baseline of any other significant ocular disease, eg. corneal edema, uveitis, ocular infection, or ocular trauma in either eye (Note: stable myopia, strabismus, and cataracts as per the Investigator’s discretion will be allowed provided that the other inclusion or exclusion criteria are met).
6. Current corneal abnormalities that would prevent accurate IOP readings with Goldmann applanation tonometer.
7. Functionally significant visual field loss in the Investigators’ opinion.
8. Subject with corneal grafts.
9. Subject has contraindication to pupil dilation.
10. Use at any time prior to baseline of an intraocular corticosteroid implant.
11. Use of contact lens within 1 week prior to baseline.
12. Use within 2 weeks prior to baseline of 1) a topical ophthalmic corticosteroid or 2) a topical corticosteroid.
13. Use within 1 month prior to baseline of 1) a systemic corticosteroid or 2) high dose salicylate therapy defined as 325 mg per day and taken on 3 consecutive days.
14. Use within 6 months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid.
15. Underwent within 6 months prior to baseline any other intraocular surgery (eg. cataract surgery).
16. Underwent within 12 months prior to baseline any refractive surgery, filtering surgery, or laser surgery for IOP reduction (eg. laser trabeculoplasty).
17. Amblyopia only one sighted eye.
18. Subjects with a history of IOP previously uncontrolled on bimatoprost monotherapy.
19. Significant ocular surface findings (eg. hyperemia or irritation, mild or greater) in either eye found on gross macroscopic or slit lamp examination.
20. Severe retinal disease or other severe ocular pathology, such as glaucomatous damage with a cup or disk ratio greater than 0.8 (not including physiological cupping in the Investigators opinion) or split fixation.
21. Chronic use of any systemic medication that may affect IOP with less than 3 months stable dosing regimen (ie. sympathomimetic agents, beta-adrenergic blocking agents, alpha-agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.)
23. Known history or presence of any uncontrolled systemic disease (eg. cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment, etc.)
24. History of recurrent ocular seasonal allergies within the past 2 years.
25. Any other medical condition or serious intercurrent illness that, in the Investigators opinion, may make it undesirable for the subject to participate in the study and would limit adherence to the study requirements.
26. Participation in any clinical study within 30 days before the first dose of study drug.
27. Subjects with known history of positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
28. Subjects with positive urine pregnancy test.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) visitsTimepoint: 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
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>analyzing nature, severity and frequency of treatment emergent adverse events. <br/ ><br>Timepoint: NA