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Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension

S

Santen

Status and phase

Completed
Phase 2
Phase 1

Conditions

Open-Angle Glaucoma
Ocular Hypertension

Treatments

Drug: 0.005% latanoprost
Drug: DE-104 medium concentration
Drug: DE-104 high concentration
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

To investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Provided signed, written informed consent.
  • 18 years of age and older.
  • Diagnosed with primary open-angle glaucoma or ocular hypertension.
  • If a subject is a female of childbearing potential she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion criteria

  • Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
  • Presence of any abnormality or significant illness that could be expected to interfere with the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

49 participants in 4 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: DE-104 medium concentration
2
Experimental group
Treatment:
Drug: DE-104 high concentration
3
Placebo Comparator group
Treatment:
Drug: Placebo
4
Active Comparator group
Treatment:
Drug: 0.005% latanoprost

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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