Skip to main content
OpenTrials
Completed

NCT Number: NCT03697811

DE-117 Spectrum 5 Study

Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Open-angle Glaucoma and Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arizona Eye Center, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.
  • Provide signed written informed consent.
  • Diagnosis of POAG or OHT in both eyes.
  • 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 after latanoprost Run-in Period.
  • Qualifying Anterior chamber angle.
  • Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.

Exclusion criteria

  • Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout.
  • Patients with prior exposure to DE-117.
  • History of ocular surgery specifically intended to lower IOP
  • 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 Visit 1 (Screening) and throughout the study in either eye.
  • Females who are pregnant, nursing, or planning a pregnancy.

Treatment and study plan

DE-117 Ophthalmic Solution

Drug

Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.

Primary outcomes

  1. Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3.

    Time frame: Month 3

    IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3.

Secondary outcomes

  1. Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3

    Time frame: week 2, 6 and month 3

    The secondary efficacy endpoint evaluated percent change from baseline in mean DIOP at week 2, 6 and month 3.

  2. Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6

    Time frame: week 2 and 6

    Change from baseline (Visit 4) in mean diurnal IOP at Week 2 (Visit 5) and Week 6 (Visit 6).

  3. Change From Baseline in IOP at Timepoints at Week 2

    Time frame: 08:00, 12:00 and 16:00 at Week 2

    Change in mean IOP were evaluated at each time point at all post-baseline visits. (Change from baseline measurement at each timepoint was calculated by deducting the baseline value at corresponding timepoint from the IOP measurement).

  4. Change From Baseline in IOP at Timepoints at Week 6

    Time frame: 08:00, 12:00 and 16:00 at Week 6

    Change in mean IOP were evaluated at each time point at all post-baseline visits.

  5. Change From Baseline in IOP at Timepoints at Month 3

    Time frame: 08:00, 12:00 and 16:00 at month 3

    Change in mean IOP were evaluated at each time point at all post-baseline visits.

  6. Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2

    Time frame: 08:00, 12:00 and 16:00 at week 2

    Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.

  7. Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6

    Time frame: 08:00, 12:00 and 16:00 at week 6

    Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.

  8. Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3

    Time frame: 08:00, 12:00 and 16:00 at month 3.

    Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Registry information

Official study title

An Open-Label, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% in Latanoprost Low/Non-Responder Subjects Diagnosed With Primary Open-Angle Glaucoma or Ocular Hypertension - Spectrum 5 Study

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2018
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.