Phase 3 N=166 Triple-blind Treatment

DE-111 Against Timolol Ophthalmic Solution 0.5%

Open Angle Glaucoma · Ocular Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01342094 ↗

Enrolled (actual)

166

Serious AEs

0.0%

Results posted

May 2015

Primary outcome: Primary: Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study — -3.2; -1.7 mmHg — p=< 0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: DE-111 ophthalmic solution (Drug); Timolol ophthalmic solution 0.5% (Drug); Placebo ophthalmic solution (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Santen Pharmaceutical Co., Ltd.
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study	-3.2; -1.7	< 0.001 sig

Summary

DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.

Eligibility Criteria

Inclusion Criteria

Diagnosed with primary 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 (NCT01342094). 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.