DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%

Phase 3

Completed

• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Interventions: Drug: DE-111 ophthalmic solution; Drug: Tafluprost ophthalmic solution 0.0015%; Drug: Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%

• Registration Number: NCT01342081
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

Brief Summary

DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and Timolol ophthalmic solution 0.5% used concomitantly, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-25
• Study First Submitted QC: 2011-04-25
• Study First Posted: 2011-04-26
• Study Start: 2011-05
• Primary Completion: 2012-09
• Results First Submitted: 2015-04-28
• Results First Submitted QC: 2015-04-28
• Status Verified: 2015-05
• Results First Posted: 2015-05-14
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 489

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	DE-111 ophthalmic solution	DE-111 ophthalmic solution
2	Tafluprost ophthalmic solution 0.0015%	Tafluprost ophthalmic solution 0.0015%
3	Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%	Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study	Week 0(Baseline) and Week 4(End of Study)	Mean diurnal IOP(intraocular pressure) was calculated as an average of IOP(intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.

Trial Locations

Locations (1)

Santen study sites; 🇯🇵 Osaka, Japan