A Phase III, Multi-center, Randomized, Single-blind (to Evaluator), Parallel, and Positive-controlled Clinical Trial Evaluating the Efficacy and Safety of OPC-1085EL Ophthalmic Solution in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Chinese Subjects

  • STATUS
    Recruiting
  • End date
    Apr 21, 2024
  • participants needed
    240
  • sponsor
    Otsuka Beijing Research Institute
Updated on 21 October 2022

Summary

It is a phase III, multi-center, randomized, single-blind (to evaluator), parallel, and positive-controlled clinical trial evaluating the efficacy and safety of OPC-1085EL in the treatment of primary open angle glaucoma or ocular hypertension in Chinese subjects. It is planned that 240 subjects (120 in each group) will be randomly assigned to receive OPC-1085EL or 0.005% latanoprost ophthalmic solution (latanoprost) at a ratio of 1:1.

Description

The trial includes 2 period:

  1. Screening period: 4 weeks. For subjects entering the screening period, 0.005% latanoprost will be administered for 4 consecutive weeks, one drop for each eye, once per day.
  2. Evaluation period: 8 weeks. Subjects who are eligible are randomly assigned to the OPC-1085EL group or 0.005% latanoprost group at a ratio of 1:1, one drop for each eye, once per day.

Details
Condition Open Angle Glaucoma or Ocular Hypertension
Treatment OPC-1085EL, 0.005% Latanoprost
Clinical Study IdentifierNCT05583474
SponsorOtsuka Beijing Research Institute
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Unlimited
Hospitalization status: Outpatients
Age: 20-80 years old
Subjects with both eyes diagnosed as primary open angle glaucoma or ocular hypertension
[At the end of the screening period]
IOP: After 4 weeks treatment with 0.005% latanoprost, the unilateral eye with a pre-dose IOP from 18 mmHg to <30 mmHg, and IOP <30 mmHg in the contralateral eye

Exclusion Criteria

Subjects with a best-corrected visual acuity ≤ 0.2
Subject with any secondary glaucoma such as exfoliative or pigmented glaucoma
Subjects who cannot stop using contact lenses during the trial
Subjects who are judged by investigators to be at risk when receiving carteolol hydrochloride or 0.005% latanoprost as monotherapy
Subjects who are allergic to any ingredients in carteolol or latanoprost
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