Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Open-angle Glaucoma or Ocular Hypertension Clinical Trial

Official title:

A Phase II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost and Placebo in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868126
• Other study ID #: 33-002
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2013
• Last updated: April 16, 2018
• Start date: May 2013
• Est. completion date: September 2013

Study information

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

Clinical Trial Summary

The purpose of this study is to investigate the safety and efficacy of four concentrations of DE-117 ophthalmic solution.

Description:

This is a 28-day randomized, observer-masked, placebo-and active-controlled, parallel-group, multi-center, study investigating the safety and efficacy of four concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) and placebo (vehicle of DE-117) in subjects with primary open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

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

• Qualifying intraocular pressure in at least one eye at Baseline

• Qualifying corrected ETDRS visual acuity in each eye

• Qualifying central cornea thickness in each eye

Main Exclusion Criteria:

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

• Diagnosis of primary open-angle glaucoma or ocular hypertension due to etiology known to be non-responsive to conventional drug therapy

• Evidence of advanced glaucoma, visual field defect or progressive visual field loss that that do not meet the study criteria

• History of ocular surgery specifically intended to lower IOP

• History of any ocular or systemic abnormality or condition that may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation in the study

• Intended or current use of any ocular medications other than study medications during the study

• Use of contact lenses within one week prior to Baseline (Day 1) until end of treatment

• Known allergy or sensitivity to any components of the study medications

• Use of steroids (systemic) within 30 days prior to Visit 1 (Screening)

• Anticipate the need to initiate or modify an existing chronic therapy that could substantially affect IOP or the study outcomes during the study period

• Females who are pregnant, nursing or planning a pregnancy

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-angle Glaucoma or Ocular Hypertension

Intervention

Drug:
• DE-117 ophthalmic solution

• latanoprost ophthalmic solution

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure (mmHg)	Intraocular pressure (mmHg) measurements will be collected at each visit using Goldmann applanation tonometry	Day 1, Day 8, Day 15 and Day 29
Secondary	Adverse events	Adverse events will be assessed at each visit to evaluate safety	Day 1, Day 8, Day 15 and Day 29
Secondary	Ocular signs and symptoms	Ocular symptoms and ocular signs will be collected at each visit using slit lamp biomicroscopy, dilated ophthalmoscopy, gonioscopy, automated perimetry visual field testing, corrected visual acuity and pachymetry	Day 1, Day 8, Day 15 and Day 29