DE-111 Against Timolol Ophthalmic Solution 0.5%

NCT01342094 | Completed Phase 3 Results

• 1 other identifier: 01111005
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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.

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 (2)

DE-111 ophthalmic solution

EXPERIMENTAL

DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.

Drug: DE-111 ophthalmic solution; Drug: Placebo ophthalmic solution

Timolol ophthalmic solution 0.5%

ACTIVE COMPARATOR

Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.

Drug: Timolol ophthalmic solution 0.5%; Drug: Placebo ophthalmic solution

Interventions

DE-111 ophthalmic solution DRUG

DE-111 ophthalmic solution

Timolol ophthalmic solution 0.5% DRUG

Timolol ophthalmic solution 0.5%

Placebo ophthalmic solution DRUG

DE-111 ophthalmic solution; Timolol ophthalmic solution 0.5%

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, 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 24, 2011
• First Posted: April 26, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2012
• Last Updated: July 10, 2015
• Results First Posted: May 15, 2015

Record last verified: 2015-06

Locations

JP (1)