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Completed

NCT Number: NCT03216902

A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss.

This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension.

The IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.

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Key information

Conditions

Open-angle Glaucoma, 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

Murakami Karindoh Hospital, Fukuoka-shi, Fukuoka, Japan

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
  • 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
  • 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 90 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

Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution

Drug

Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks

Topical ultra-low dose of DE-126 Ophthalmic Solution

Drug

Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks

Topical low dose of DE-126 Ophthalmic Solution

Drug

Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks

Topical medium dose of DE-126 Ophthalmic Solution

Drug

Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks

Topical high dose of DE-126 Ophthalmic Solution

Drug

Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks

0.005% Latanoprost Ophthalmic Solution

Drug

0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks

Other names: Xalatan®

Primary outcomes

  1. Intraocular Pressure in the Study Eye at Month 3

    Time frame: 9:00, 13:00 and 17:00 at Month 3

    Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.

Secondary outcomes

  1. Intraocular Pressure in the Study Eye at Week 6

    Time frame: 9:00, 13:00 and 17:00 at Week 6

    Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.

  2. Intraocular Pressure in the Study Eye at Week 1 and Week 2

    Time frame: 9:00, 13:00 and 17:00 at Week 1 and Week 2

    Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.

  3. Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit

    Time frame: Week 1, Week 2, Week 6 and Month 3.

    Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.

  4. Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit

    Time frame: Week 1, Week 2, Week 6 and Month 3.

    Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.

  5. Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit

    Time frame: Week 1, Week 2, Week 6 and Month 3.

    Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.

  6. Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit

    Time frame: 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.

    Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.

  7. Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit

    Time frame: 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.

    Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.

  8. Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit

    Time frame: WeeK 1, Week 2, Week 6 and Month 3.

    A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 20%.

    A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 25%.

    A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 30%.

  9. Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit

    Time frame: Week 1, Week 2, Week 6 and Month 3.

    A subject was a responder if the mean diurnal IOP in the study eye was ≤ 18 mmHg.

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Registry information

Official study title

A Phase IIb, Randomized, Observer-Masked, Placebo- and Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-126 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 13, 2017
Registry last updated
Oct 23, 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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