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Trial record 3 of 11 for:    de-117

A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study

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ClinicalTrials.gov Identifier: NCT03691662
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Brief Summary:

This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months.

Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:

  • DE-117 Ophthalmic Solution once daily and Vehicle once daily, or
  • Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3.

Condition or disease Intervention/treatment Phase
Glaucoma and Ocular Hypertension Drug: DE-117 Ophthalmic Solution Drug: Timolol Maleate Ophthalmic Solution 0.5% Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study
Actual Study Start Date : September 13, 2018
Estimated Primary Completion Date : June 3, 2019
Estimated Study Completion Date : October 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: DE-117 Ophthalmic Solution
Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months
Drug: DE-117 Ophthalmic Solution
Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months

Active Comparator: Timolol Maleate Ophthalmic Solution 0.5%
Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months
Drug: Timolol Maleate Ophthalmic Solution 0.5%
Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months




Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: Week 1, Week 6 and Month 3 ]
    Change in IOP


Secondary Outcome Measures :
  1. Intraocular pressure [ Time Frame: Week 1, Month 3 ]
    Decrease in mean diurnal IOP reduction



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• glaucoma or ocular hypertension

Exclusion Criteria:

  • Females who are pregnant, nursing, or planning a pregnancy
  • Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691662


Contacts
Contact: Santen Inc Clinical Operations (415) 268-9052 clinicaltrials@santen.com

  Show 36 Study Locations
Sponsors and Collaborators
Santen Inc.

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT03691662     History of Changes
Other Study ID Numbers: 011710IN
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors