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Completed

NCT Number: NCT03858894

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

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.

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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 2

Primary location

East West Eye Institute, Los Angeles, California, 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

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

Treatment and study plan

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

Primary outcomes

  1. Intraocular Pressure (IOP) at Week 2

    Time frame: 08:00 at week 2

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

  2. Intraocular Pressure (IOP) at Week 2

    Time frame: 12:00 at week 2

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

  3. Intraocular Pressure (IOP) at Week 2

    Time frame: 16:00 at week 2

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

  4. Intraocular Pressure (IOP) at Week 6

    Time frame: 08:00 at week 6

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

  5. Intraocular Pressure (IOP) at Week 6

    Time frame: 12:00 at week 6

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

  6. Intraocular Pressure (IOP) at Week 6

    Time frame: 16:00 at week 6

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

Secondary outcomes

  1. Mean Diurnal Intraocular Pressure (IOP)

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Registry information

Official study title

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.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2019
Registry last updated
Aug 4, 2020

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.

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