Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6

NCT03858894 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 011712IN
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 13

Brief Summary

This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their current topical IOP lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up to 6 weeks. Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:

• DE-117 ophthalmic solution 0.002% QD (Once Daily)
• DE-117 ophthalmic solution 0.002% BID (Twice Daily) This study will consist of a screening period of up to 35 days including a washout period of up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.

Conditions

Primary Open-angle Glaucoma and Ocular Hypertension

Outcome Measures

Primary Outcomes (6)

• Intraocular Pressure (IOP) at Week 2

  Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

  08:00 at week 2

• Intraocular Pressure (IOP) at Week 2

  Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

  12:00 at week 2

• Intraocular Pressure (IOP) at Week 2

  Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...

  16:00 at week 2

• Intraocular Pressure (IOP) at Week 6

  Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

  08:00 at week 6

• Intraocular Pressure (IOP) at Week 6

  Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

  12:00 at week 6

• Intraocular Pressure (IOP) at Week 6

  Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...

  16:00 at week 6

Secondary Outcomes (1)

• Mean Diurnal Intraocular Pressure (IOP)

  6 weeks

Study Arms (2)

Drug Arm: DE-117 QD

EXPERIMENTAL

DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD

Drug: DE-117 Ophthalmic Solution QD

Test Arm: DE-117 BID

EXPERIMENTAL

DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)

Drug: DE-117 Ophthalmic Solution BID

Interventions

DE-117 Ophthalmic Solution QD DRUG

DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye

Drug Arm: DE-117 QD

DE-117 Ophthalmic Solution BID DRUG

DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye

Test Arm: DE-117 BID

Eligibility Criteria

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

You may qualify if:

• Provide signed written informed consent
• Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
• Qualifying corrected visual acuity in each eye
• Qualifying central corneal thickness in each eye
• Qualifying Day 1 IOP measurement at 3 time-points in both eyes
• Qualifying Anterior chamber angle

You may not qualify if:

• History of ocular surgery specifically intended to lower IOP
• Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
• Advanced glaucoma in either eye
• Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry
• Any ocular surgery or ocular laser treatment within 180 days prior to Screening and throughout the study in either eye
• Females who are pregnant, nursing, or planning a pregnancy

Sponsors & Collaborators

• Santen Inc.: lead

Study Sites (13)

East West Eye Institute

Los Angeles, California, 90013, United States

Location

Danbury Eye Specialist

Danbury, Connecticut, 06810, United States

Location

Hernando Eye Institute

Brooksville, Florida, 34613, United States

Location

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

Location

Seidenberg Protzko Eye Associates

Havre de Grace, Maryland, 21078, United States

Location

Tekwani Vision Center

St Louis, Missouri, 63128, United States

Location

Eye Associates/SurgiCenter of Vineland

Vineland, New Jersey, 08361, United States

Location

Ophthalmic Consultants of Long Island

Lynbrook, New York, 11563, United States

Location

Apex Eye Clinical Research, LLC

Cincinnati, Ohio, 45242, United States

Location

Abrams Eye Center

Cleveland, Ohio, 44115, United States

Location

Scott & Christie and Associates PC

Cranberry Township, Pennsylvania, 16066, United States

Location

University Eye Specialist

Maryville, Tennessee, 37803, United States

Location

Advanced Vision Research

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Results Point of Contact

• Title: R&D Quality Manager
• Organization: Santen Inc

evelyn.chikere@santen.com

415 268 9199

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: January 28, 2019
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2019
• Last Updated: August 4, 2020
• Results First Posted: August 4, 2020

Record last verified: 2020-07

Locations

US (13)