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

NCT01868126 | Completed Phase 2

• 1 other identifier: 33-002
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Open-angle Glaucoma or Ocular Hypertension

Keywords

Santen; Eye; Glaucoma; Ocular hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adverse events

  Day 1, Day 8, Day 15 and Day 29

• Ocular signs and symptoms

  Day 1, Day 8, Day 15 and Day 29

Study Arms (6)

Group 1: DE-117 ophthalmic solution

EXPERIMENTAL

One drop DE-117 Low Dose in each eye daily for 28 days

Drug: DE-117 ophthalmic solution

Group 2: DE-117 ophthalmic solution

EXPERIMENTAL

One drop DE-117 Low Middle Dose in each eye daily for 28 days

Drug: DE-117 ophthalmic solution

Group 3: DE-117 ophthalmic solution

EXPERIMENTAL

One drop DE-117 High Middle Dose in each eye daily for 28 days

Drug: DE-117 ophthalmic solution

Group 4: DE-117 ophthalmic solution

EXPERIMENTAL

One drop DE-117 High Dose in each eye daily for 28 days

Drug: DE-117 ophthalmic solution

latanoprost ophthalmic solution

ACTIVE COMPARATOR

One drop latanoprost 0.005% in each eye daily for 28 days

Drug: latanoprost ophthalmic solution

placebo (vehicle of DE-117) ophthalmic solution

PLACEBO COMPARATOR

One drop DE-117 vehicle in each eye once daily for 28 days

Other: Placebo

Interventions

DE-117 ophthalmic solution DRUG

Group 1: DE-117 ophthalmic solution; Group 2: DE-117 ophthalmic solution; Group 3: DE-117 ophthalmic solution; Group 4: DE-117 ophthalmic solution

latanoprost ophthalmic solution DRUG

latanoprost ophthalmic solution

Placebo OTHER

placebo (vehicle of DE-117) ophthalmic solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Santen Inc.: lead

Study Sites (7)

Unknown Facility

Newport Beach, California, 92663, United States

Location

Unknown Facility

Morrow, Georgia, 30260, United States

Location

Unknown Facility

Kansas City, Missouri, 64133, United States

Location

Unknown Facility

Rochester, New York, 14618, United States

Location

Unknown Facility

Cleveland, Ohio, 44115, United States

Location

Unknown Facility

Austin, Texas, 78731, United States

Location

Unknown Facility

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 4, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

US (7)