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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01654484
Other study ID # 33-001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received July 27, 2012
Last updated April 16, 2018
Start date July 2012
Est. completion date November 2012

Study information

Verified date April 2018
Source Santen Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety and efficacy of up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular hypertension.


Description:

This is a two stage study.

Stage One will explore the dose response of three concentrations of DE-117 as monotherapy compared with 0.0015% tafluprost and placebo. The safety and efficacy of DE-117 as adjunctive therapy (with 0.0015% tafluprost) compared with 0.0015% tafluprost and placebo will also be evaluated. In addition, the additive effect of adjunctive therapy of each concentration will be compared with the corresponding monotherapy concentration.

Stage Two will assess the safety and efficacy of the optimal DE-117 concentration as monotherapy compared with 0.0015% tafluprost. The safety and efficacy of the optimal DE-117 concentration as adjunctive therapy (with 0.0015% tafluprost) compared with DE-117 monotherapy and 0.0015% tafluprost will also be evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male or Female, 18 years of age or older

2. Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes

3. Qualifying intraocular pressure (IOP) in at least one eye at Baseline

Exclusion Criteria:

1. Closed/barely open anterior chamber angle or a history of acute angle closure in either eye

2. Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period

3. Females who are pregnant, nursing or planning a pregnancy

4. Presence of any abnormality or significant illness that could be expected to interfere with the study.

Study Design


Intervention

Drug:
DE-117
Ophthalmic Solution, QD, 28 Days
0.0015% tafluprost
Ophthalmic Solution, QD, 28 days
DE-117 and 0.0015% tafluprost
Ophthalmic Solutions, QD, 28 days
Placebo
Ophthalmic Solution, QD, 28 days

Locations

Country Name City State
United States Santen Investigational Site Austin Texas
United States Santen Investigational Site Cleveland Ohio
United States Santen Investigational Site Deerfield Beach Florida
United States Santen Investigational Site Fort Worth Texas
United States Santen Investigational Site Largo Florida
United States Santen Investigational Site Morrow Georgia
United States Santen Investigational Site Newport Beach California
United States Santen Investigational Site Rochester New York
United States Santen Investigational Site Roswell Georgia
United States Santen Investigational Site San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Santen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point Day 28 T0 (08:00 ±30 mins), T0+2 hrs, T0+4 hrs, T0+8 hrs
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