A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen Inc.
ClinicalTrials.gov Identifier:
NCT01654484
First received: July 27, 2012
Last updated: December 14, 2012
Last verified: October 2012

July 27, 2012
December 14, 2012
July 2012
November 2012   (final data collection date for primary outcome measure)
Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point [ Time Frame: Day 28 T0 (08:00 ±30 mins), T0+2 hrs, T0+4 hrs, T0+8 hrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01654484 on ClinicalTrials.gov Archive Site
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Not Provided
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A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT
A Phase I/II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Glaucoma and Ocular Hypertension
  • Drug: DE-117
    Ophthalmic Solution, QD, 28 Days
  • Drug: 0.0015% tafluprost
    Ophthalmic Solution, QD, 28 days
  • Drug: DE-117 and 0.0015% tafluprost
    Ophthalmic Solutions, QD, 28 days
  • Drug: Placebo
    Ophthalmic Solution, QD, 28 days
  • Experimental: Low Dose DE-117
    Monotherapy
    Intervention: Drug: DE-117
  • Experimental: Medium Dose DE-117
    Monotherapy
    Intervention: Drug: DE-117
  • Experimental: High Dose DE-117
    Monotherapy
    Intervention: Drug: DE-117
  • Experimental: Low Dose DE-117 and 0.0015% tafluprost
    Adjunctive Therapy
    Intervention: Drug: DE-117 and 0.0015% tafluprost
  • Experimental: Med. Dose DE-117 and 0.0015% tafluprost
    Adjunctive Therapy
    Intervention: Drug: DE-117 and 0.0015% tafluprost
  • Experimental: High Dose DE-117 and 0.0015% tafluprost
    Adjunctive Therapy
    Intervention: Drug: DE-117 and 0.0015% tafluprost
  • Active Comparator: 0.0015% tafluprost
    Monotherapy
    Intervention: Drug: 0.0015% tafluprost
  • Placebo Comparator: Placebo
    Monotherapy
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01654484
33-001
No
Santen Inc.
Santen Inc.
Not Provided
Not Provided
Santen Inc.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP