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Trial record 1 of 1 for:    NCT03216902
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A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03216902
Recruitment Status : Completed
First Posted : July 13, 2017
Results First Posted : October 23, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Open-angle Glaucoma, Ocular Hypertension Drug: Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution Drug: Topical ultra-low dose of DE-126 Ophthalmic Solution Drug: Topical low dose of DE-126 Ophthalmic Solution Drug: Topical medium dose of DE-126 Ophthalmic Solution Drug: Topical high dose of DE-126 Ophthalmic Solution Drug: 0.005% Latanoprost Ophthalmic Solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 25, 2017
Actual Primary Completion Date : February 27, 2018
Actual Study Completion Date : February 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Placebo Comparator: Placebo (Vehicle of DE-126) followed by high dose of DE-126 Drug: Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution
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

Experimental: Ultra-low dose 0.0005% DE-126 Drug: Topical ultra-low dose of DE-126 Ophthalmic Solution
Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks

Experimental: Low dose 0.001% DE-126 Drug: Topical low dose of DE-126 Ophthalmic Solution
Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks

Experimental: Medium dose 0.002% DE-126 Drug: Topical medium dose of DE-126 Ophthalmic Solution
Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks

Experimental: High dose 0.003% DE-126 Drug: Topical high dose of DE-126 Ophthalmic Solution
Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks

Active Comparator: 0.005% Latanoprost Drug: 0.005% Latanoprost Ophthalmic Solution
0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
Other Name: Xalatan®




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216902


Locations
Show Show 17 study locations
Sponsors and Collaborators
Santen Inc.
  Study Documents (Full-Text)

Documents provided by Santen Inc.:
Study Protocol  [PDF] June 16, 2017
Statistical Analysis Plan  [PDF] March 27, 2018

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Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT03216902    
Other Study ID Numbers: 012601IN
First Posted: July 13, 2017    Key Record Dates
Results First Posted: October 23, 2020
Last Update Posted: October 23, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Santen Inc.:
Glaucoma
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents