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

Ocular Hypertension Clinical Trial

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Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179008
• Other study ID #: 33-003
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2014
• Last updated: April 16, 2018
• Start date: June 2014
• Est. completion date: January 2015

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 five concentrations of DE-117 ophthalmic solution.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• DE-117 Low Dose ophthalmic solution
Low Dose DE-117 ophthalmic solution
• DE-117 Low/Middle Dose ophthalmic solution
Low/Middle Dose DE-117
• DE-117 Middle Dose ophthalmic solution
Middle Dose DE-117
• DE-117 Middle/High Dose ophthalmic solution
Middle/High Dose DE-117
• DE-117 High Dose ophthalmic solution
High Dose DE-117
• latanoprost ophthalmic solution 0.005%
0.005% latanoprost

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