Phase 3 N=148 Treatment

DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

Open Angle Glaucoma or Ocular Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01343082 ↗

Enrolled (actual)

148

Serious AEs

4.4%

Results posted

May 2015

Primary outcome: Primary: Change From Baseline in IOP (Intraocular Pressure) at End of Study — -1.8 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: DE-111 ophthalmic solution (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Santen Pharmaceutical Co., Ltd.
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in IOP (Intraocular Pressure) at End of Study	-1.8	—

Summary

Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.

Eligibility Criteria

Inclusion Criteria

Diagnosed with open angle glaucoma or ocular hypertension
Provided signed, written informed consent
20 years of age and older
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01343082). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.