Bioequivalence study with clinical endpoint in the treatment of subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.

Not Applicable

Active, not recruiting

• Conditions: Health Condition 1: H401- Open-angle glaucoma

• Registration Number: CTRI/2022/04/042203
• Lead Sponsor: Amneal EU Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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 having body mass index (BMI) Greater than or equal to18.50 kg per m2

4. Subjects with chronic open angle glaucoma or ocular hypertension in both eyes

5. 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

6. 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

7. Baseline (Day 0 per hour 0) IOP Greater than or equal to21mm Hg and less than 34 mm Hg in each eye, with difference between the IOP in left and right eyes not being more than 5 mm Hg

8. Subjects IOP is likely to be controlled with monotherapy as per the Investigators discretion

9.

10. 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

11. No history of addiction to any recreational drug or drug dependence or alcohol addiction.

Exclusion Criteria

1. Female who are pregnant, lactating or planning a pregnancy

2. Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation

3. Current or past history of severe hepatic or renal impairment

4. Current or history within 2 months prior to 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 the Investigatorâ??s discretion will be allowed provided that the other inclusion/exclusion criteria are met)

5.

6. Functionally significant visual field loss in the Investigatorsâ?? opinion

7. Subject with corneal grafts

8. Subject has contraindication to pupil dilation

9. Use at any time prior to baseline of an intraocular corticosteroid implant

10. Use of contact lens within 1 week prior to baseline

11. Use within 2 weeks prior to baseline of 1) a topical ophthalmic corticosteroid or 2) a topical corticosteroid

13. Use within 6 months prior to baseline of intravitreal or subtenon injection of an ophthalmic corticosteroid

14. Underwent within 6 months prior to baseline any other intraocular surgery (e.g., cataract surgery)

15. Underwent within 12 months prior to baseline any refractive surgery, filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty)

16. Amblyopia - only one sighted eye

17. Subjects with a history of IOP previously uncontrolled on bimatoprost monotherapy

18. Significant ocular surface findings (e.g., hyperemia or irritation, mild or greater) in either eye found on gross macroscopic or slit lamp examination

19. Known history or presence of any uncontrolled systemic disease (e.g., cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment, etc.)

20. History of recurrent ocular seasonal allergies within the past 2 years

21. Any other medical condition or serious intercurrent illness that, in the Investigatorâ??s opinion, may make it undesirable for the subject to participate in the study and would limit adherence to the study requirements

22. Participation in any clinical study within 90 days before the first dose of the study drug

23. Subjects with documented history of positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection

24. Subjects with positive urine pregnancy test

25. Subjects with confirmed novel coronavirus infection (COVID-19)

Study & Design

• Study Type: Interventional
• Study Design: Not specified