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

NCT01342081 | Completed Phase 3 Results

• 1 other identifier: 01111004
• Study Type: interventional
• Target: 489
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Keywords

Primary open angle glaucoma or ocular hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at 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.

  Week 0(Baseline) and Week 4(End of Study)

Study Arms (3)

1

EXPERIMENTAL

DE-111 ophthalmic solution

Drug: DE-111 ophthalmic solution

2

ACTIVE COMPARATOR

Tafluprost ophthalmic solution 0.0015%

Drug: Tafluprost ophthalmic solution 0.0015%

3

ACTIVE COMPARATOR

Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%

Drug: Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%

Interventions

DE-111 ophthalmic solution DRUG

1

Tafluprost ophthalmic solution 0.0015% DRUG

2

Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5% DRUG

3

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with primary open angle glaucoma or ocular hypertension
• Provided signed, written informed consent
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santen Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Santen study sites

Osaka, Japan

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Results Point of Contact

• Title: General Manager of Clinical Development Group
• Organization: Santen Pharmaceutical Co., Ltd.

clinical@santen.co.jp

+81-6-4802-9341

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: April 26, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2012
• Last Updated: June 15, 2015
• Results First Posted: May 14, 2015

Record last verified: 2015-05

Locations

JP (1)