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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02179008

Acronym

SEE-1

Enrollment

184

Registered

2014-07-01

Start date

2014-06-30

Completion date

2015-01-31

Last updated

2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-angle Glaucoma, Ocular Hypertension

Keywords

Santen, Eye, Glaucoma, Ocular hypertension

Brief summary

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

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.

Interventions

DRUGDE-117 Low Dose ophthalmic solution

Low Dose DE-117 ophthalmic solution

DRUGDE-117 Low/Middle Dose ophthalmic solution

Low/Middle Dose DE-117

DRUGDE-117 Middle Dose ophthalmic solution

Middle Dose DE-117

DRUGDE-117 Middle/High Dose ophthalmic solution

Middle/High Dose DE-117

DRUGDE-117 High Dose ophthalmic solution

High Dose DE-117

DRUGlatanoprost ophthalmic solution 0.005%

0.005% latanoprost

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Intraocular pressure (mmHg)	Day 91	Intraocular pressure (mmHg) measurements will be collected using Goldmann applanation tonometry

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026