DE-117 Spectrum 5 Study

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Primary Open-angle Glaucoma and Ocular Hypertension

Intervention / Treatment
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* Drug: DE-117 Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DE-117 Ophthalmic Solution 0.002%<br>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. | Drug: DE-117 Ophthalmic Solution<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at 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. | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3 | The secondary efficacy endpoint evaluated percent change from baseline in mean DIOP at week 2, 6 and month 3. | week 2, 6 and month 3 | 
| Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6 | Change from baseline (Visit 4) in mean diurnal IOP at Week 2 (Visit 5) and Week 6 (Visit 6). | week 2 and 6 | 
| Change From Baseline in IOP at Timepoints 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). | 08:00, 12:00 and 16:00 at Week 2 | 
| Change From Baseline in IOP at Timepoints at Week 6 | Change in mean IOP were evaluated at each time point at all post-baseline visits. | 08:00, 12:00 and 16:00 at Week 6 | 
| Change From Baseline in IOP at Timepoints at Month 3 | Change in mean IOP were evaluated at each time point at all post-baseline visits. | 08:00, 12:00 and 16:00 at month 3 | 
| Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2 | Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint. | 08:00, 12:00 and 16:00 at week 2 | 
| Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6 | Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint. | 08:00, 12:00 and 16:00 at week 6 | 
| Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3 | Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint. | 08:00, 12:00 and 16:00 at month 3. |