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Clinical Trials/CTRI/2022/04/042203
CTRI/2022/04/042203
Active, not recruiting
未知

A randomized, double-blind, multiple dose, parallel-group, two-arm, multicenter, bioequivalence study with clinical endpoint comparing 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.

Amneal EU Limited0 sites0 target enrollmentTBD
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Amneal EU Limited
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Amneal EU Limited

Eligibility Criteria

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
  • •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

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)
  • •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

Outcomes

Primary Outcomes

Not specified

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