Safety and Efficacy Study of DE-104 Ophthalmic Solution t... | NCT00650338

Studies
Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension

NCT00650338

Sponsor

Santen Inc.

Status

Completed

Last Update Posted

Nov 3, 2011Estimated

Enrollment

165Estimated

Phase

Phase 2

Conditions

Open-Angle Glaucoma
Ocular Hypertension

Interventions

DE-104 ophthalmic solution, low concentration
DE-104 ophthalmic solution, medium concentration
DE-104 ophthalmic solution, high concentration
Placebo
0.005% latanoprost

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Mar 27, 2008

First Submission Date that Met QC Criteria

Mar 31, 2008

First Posted Date

Apr 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2011

Last Update Posted Date

Nov 3, 2011Estimated

Description Module

Brief Summary

To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

165Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	<described in intervention>	Drug: DE-104 ophthalmic solution, low concentration
2	Experimental	<described in intervention>	Drug: DE-104 ophthalmic solution, medium concentration
3	Experimental	<described in intervention>	Drug: DE-104 ophthalmic solution, high concentration
4	Placebo Comparator	<described in intervention>	Drug: Placebo
5	Active Comparator	<described intervention>	Drug: 0.005% latanoprost

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DE-104 ophthalmic solution, low concentration	Drug	Topical ocular application	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)		28 days

Secondary Outcomes

Measure	Description	Time Frame
To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.		35 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provided signed, written informed consent.
Diagnosed with primary open-angle glaucoma or ocular hypertension.
18 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sall Research Medical Center		Artesia	California	90701	United States
USC Department of Ophthalmology

Type	Date	Date Unknown
Release	Apr 14, 2017
Reset	May 19, 2017

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

Estimated Results First Submitted Date

Apr 14, 2017

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 14, 2017			May 19, 2017

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

ID	Term
D005901	Glaucoma
D005128	Eye Diseases

ID	Term
D000077338	Latanoprost

Ancestor Terms

ID	Term
D011461	Prostaglandins F, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids
D008055	Lipids
D012898	Autacoids
D018836	Inflammation Mediators
D001685	Biological Factors