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 — Phase 2, Completed, 98 participants, Santen Inc.
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

A Randomized, Double-Masked, Parallel-Group, Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension SPECTRUM 6 Study.

RegistryNCT03858894
StatusCompleted
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment98 (Actual)
SponsorSanten Inc. (Industry)
ConditionsPrimary Open-angle Glaucoma and Ocular Hypertension
InterventionsDE-117 Ophthalmic Solution QD, DE-117 Ophthalmic Solution BID (Drug)
Datesstart 2019-01-28, primary completion 2019-06-20, completion 2019-06-20, first posted 2019-03-01, last updated 2020-08-04
Locations13 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Primary Open-angle Glaucoma and Ocular Hypertension All trials of DE-117 Ophthalmic Solution QD All trials of DE-117 Ophthalmic Solution BID

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Drug Arm: DE-117 QDExperimentalDrug: DE-117 Ophthalmic Solution QDDE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD
Test Arm: DE-117 BIDExperimentalDrug: DE-117 Ophthalmic Solution BIDDE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)
  • 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
  • DE-117 Ophthalmic Solution BID (Drug): DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye

+Outcome measures

Primary outcomes

  • Intraocular Pressure (IOP) at Week 2 [08:00 at week 2]: Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
  • Intraocular Pressure (IOP) at Week 2 [12:00 at week 2]: Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
  • Intraocular Pressure (IOP) at Week 2 [16:00 at week 2]: Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
  • Intraocular Pressure (IOP) at Week 6 [08:00 at week 6]: Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
  • Intraocular Pressure (IOP) at Week 6 [12:00 at week 6]: Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
  • Intraocular Pressure (IOP) at Week 6 [16:00 at week 6]: Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...

Secondary outcomes

  • Mean Diurnal Intraocular Pressure (IOP) [6 weeks]: Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* 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

+Posted results

Participant flow

MilestoneTest Arm: DE-117 BIDDrug Arm: DE-117 QD
Started4850
Completed4450
Not completed40

Outcome results

  • Intraocular Pressure (IOP) at Week 2 (Primary), Least squares mean, mmHg: Test Arm: DE-117 BID 18.19 +/- 0.46; Drug Arm: DE-117 QD 19.15 +/- 0.45
  • Intraocular Pressure (IOP) at Week 2 (Primary), Least squares mean, mmHg: Test Arm: DE-117 BID 17.73 +/- 0.49; Drug Arm: DE-117 QD 18.17 +/- 0.46
  • Intraocular Pressure (IOP) at Week 2 (Primary), Least squares mean, mmHg: Test Arm: DE-117 BID 16.73 +/- 0.47; Drug Arm: DE-117 QD 17.81 +/- 0.44
  • Intraocular Pressure (IOP) at Week 6 (Primary), Least squares mean, mmHg: Test Arm: DE-117 BID 18.33 +/- 0.49; Drug Arm: DE-117 QD 19.01 +/- 0.47
  • Intraocular Pressure (IOP) at Week 6 (Primary), Least squares mean, mmHg: Test Arm: DE-117 BID 17.77 +/- 0.45; Drug Arm: DE-117 QD 18.35 +/- 0.43
  • Intraocular Pressure (IOP) at Week 6 (Primary), Least squares mean, mmHg: Test Arm: DE-117 BID 17.30 +/- 0.45; Drug Arm: DE-117 QD 17.66 +/- 0.43
  • Mean Diurnal Intraocular Pressure (IOP) (Secondary), Least squares mean, mmHg: Test Arm: DE-117 BID 17.77 +/- 0.43; Drug Arm: DE-117 QD 18.37 +/- 0.41

Adverse events

Time frame: All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.

ArmDeathsSerious adverse eventsOther adverse events
Test Arm: DE-117 BID0/48 (0.0%)0/48 (0.0%)20/48 (41.7%)
Drug Arm: DE-117 QD0/50 (0.0%)1/50 (2.0%)7/50 (14.0%)

Serious adverse events by term

TermOrgan systemTest Arm: DE-117 BIDDrug Arm: DE-117 QD
CholelithiasisHepatobiliary disorders0/481/50

Other adverse events by term

TermOrgan systemTest Arm: DE-117 BIDDrug Arm: DE-117 QD
Conjunctival hyperaemiaEye disorders6/480/50
Ocular hyperaemiaEye disorders5/481/50
Accommodation disorderEye disorders1/480/50
Corneal pigmentationEye disorders1/480/50
Eye painEye disorders1/481/50
Eye pruritusEye disorders1/480/50
GlareEye disorders1/480/50
IridocyclitisEye disorders1/480/50
IritisEye disorders1/480/50
Ocular discomfortEye disorders1/480/50
PhotophobiaEye disorders1/482/50
Vision blurredEye disorders1/480/50
Visual impairmentEye disorders1/481/50
Punctate keratitisEye disorders0/481/50
Vital dye staining cornea presentInvestigations2/481/50
NauseaGastrointestinal disorders1/480/50
Upper respiratory tract infectionInfections and infestations1/480/50
Upper limb fractureInjury, poisoning and procedural complications1/480/50
HeadacheNervous system disorders1/482/50
Device dislocationProduct Issues1/480/50
AnaemiaBlood and lymphatic system disorders0/481/50
Myelodysplastic syndromeNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/481/50

+Locations (13)

FacilityCityCountryStatus
East West Eye InstituteLos Angeles, CaliforniaUnited States
Danbury Eye SpecialistDanbury, ConnecticutUnited States
Hernando Eye InstituteBrooksville, FloridaUnited States
Levenson Eye AssociatesJacksonville, FloridaUnited States
Seidenberg Protzko Eye AssociatesHavre de Grace, MarylandUnited States
Tekwani Vision CenterSt Louis, MissouriUnited States
Eye Associates/SurgiCenter of VinelandVineland, New JerseyUnited States
Ophthalmic Consultants of Long IslandLynbrook, New YorkUnited States
Apex Eye Clinical Research, LLCCincinnati, OhioUnited States
Abrams Eye CenterCleveland, OhioUnited States
Scott & Christie and Associates PCCranberry Township, PennsylvaniaUnited States
University Eye SpecialistMaryville, TennesseeUnited States
Advanced Vision ResearchNashville, TennesseeUnited States

+Study documents