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NCT Number: NCT01654484

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

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.

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Key information

Conditions

Glaucoma and Ocular Hypertension Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Santen Investigational Site, Newport Beach, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female, 18 years of age or older
  • Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
  • Qualifying intraocular pressure (IOP) in at least one eye at Baseline

Exclusion criteria

  • Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
  • Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period
  • Females who are pregnant, nursing or planning a pregnancy
  • Presence of any abnormality or significant illness that could be expected to interfere with the study.

Treatment and study plan

DE-117

Drug

Ophthalmic Solution, QD, 28 Days

0.0015% tafluprost

Drug

Ophthalmic Solution, QD, 28 days

DE-117 and 0.0015% tafluprost

Drug

Ophthalmic Solutions, QD, 28 days

Placebo

Drug

Ophthalmic Solution, QD, 28 days

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 31, 2012
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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