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A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT

S

Santen

Status and phase

Completed
Phase 3

Conditions

Open Angle Glaucoma or Ocular Hypertension

Treatments

Drug: Latanoprost ophthalmic solution
Drug: DE-117

Study type

Interventional

Funder types

Industry

Identifiers

NCT02981446
01171505

Details and patient eligibility

About

The purpose of this study is to investigate the intraocular pressure-lowering effect and the safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in subjects with open angle glaucoma or ocular hypertension.

Enrollment

370 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with open angle glaucoma or ocular hypertension in both eyes

Exclusion criteria

  • Patients at risk of progression of visual field loss
  • Patients with severe visual field defect
  • Patients with any diseases that preclude participation in this study for safety reasons

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

370 participants in 2 patient groups

DE-117 ophthalmic solution
Experimental group
Treatment:
Drug: DE-117
Latanoprost ophthalmic solution 0.005%
Active Comparator group
Treatment:
Drug: Latanoprost ophthalmic solution

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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