SEE-1: Multi-center Phase II Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Sponsor

Santen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02179008

Collaborator

(none)

184

Enrollment

Locations

Arms

Duration (Months)

13.1

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma Ocular Hypertension	Drug: DE-117 Low Dose ophthalmic solution Drug: DE-117 Low/Middle Dose ophthalmic solution Drug: DE-117 Middle Dose ophthalmic solution Drug: DE-117 Middle/High Dose ophthalmic solution Drug: DE-117 High Dose ophthalmic solution Drug: latanoprost ophthalmic solution 0.005%	Phase 2

Detailed Description

This is a 90-day randomized, observer-masked, active-controlled, parallel-group, multi-center, study assessing the safety and efficacy of five concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) in subjects with primary open-angle glaucoma or ocular hypertension.

Study Design

Study Type:

Interventional

Actual Enrollment :

184 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DE-117 Low Dose ophthalmic solution One drop Low Dose DE-117 in each eye QD for 90 days	Drug: DE-117 Low Dose ophthalmic solution Low Dose DE-117 ophthalmic solution Other Names: DE-117
Experimental: DE-117 Low/Middle Dose ophthalmic solution One drop DE-117 Low/Middle Dose ophthalmic solution in each eye QD for 90 days	Drug: DE-117 Low/Middle Dose ophthalmic solution Low/Middle Dose DE-117 Other Names: DE-117
Experimental: DE-117 Middle Dose ophthalmic solution One drop Middle Dose DE-117 in each eye QD for 90 days	Drug: DE-117 Middle Dose ophthalmic solution Middle Dose DE-117 Other Names: DE-117
Experimental: DE-117 Middle/High Dose ophthalmic solution One drop Middle/High Dose DE-117 in each eye QD for 90 days	Drug: DE-117 Middle/High Dose ophthalmic solution Middle/High Dose DE-117 Other Names: DE-117
Experimental: DE-117 High Dose ophthalmic solution One drop High Dose DE-117 in each eye QD for 90 days	Drug: DE-117 High Dose ophthalmic solution High Dose DE-117 Other Names: DE-117
Active Comparator: latanoprost ophthalmic solution 0.005% One drop latanaprost in each eye QD for 90 days	Drug: latanoprost ophthalmic solution 0.005% 0.005% latanoprost Other Names: latanoprost

Outcome Measures

Primary Outcome Measures

Intraocular pressure (mmHg) [Day 91]
Intraocular pressure (mmHg) measurements will be collected using Goldmann applanation tonometry

Secondary Outcome Measures

Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [Day 1, Day 8, Day 15, Day 31, Day 61 and Day 91]
Adverse events will be assessed at each visit to evaluate safety

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Chandler	Arizona	United States	85225
2	Artesia	California	United States	90701
3	Glendale	California	United States	91204
4	Long Beach	California	United States	90806
5	Newport Beach	California	United States	92663
6	Largo	Florida	United States	33773
7	Morrow	Georgia	United States	30260
8	Roswell	Georgia	United States	30076
9	Rochester	New York	United States	14618
10	High Point	North Carolina	United States	27262
11	Cleveland	Ohio	United States	44115
12	Austin	Texas	United States	78731
13	Houston	Texas	United States	77005
14	San Antonio	Texas	United States	78240