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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DE-117 Ophthalmic Solution 0.002% | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Eye Center | Chandler | Arizona | 85225 | United States | ||
| Global Research Management |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37853676 | Derived | Panarelli JF, Bowden EC, Tepedino ME, Odani-Kawabata N, Pei Z, McLaurin EB, Ropo A. Omidenepag Isopropyl in Latanoprost Low/Nonresponders With Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 3, Nonrandomized, Two-Phase, Open-Label Study. J Glaucoma. 2023 Dec 1;32(12):999-1005. doi: 10.1097/IJG.0000000000002321. Epub 2023 Oct 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DE-117 Ophthalmic Solution 0.002% | 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. DE-117 Ophthalmic Solution: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 18, 2018 | Jun 26, 2023 |
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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. |
| Glendale |
| California |
| 91204 |
| United States |
| North Valley Eye Medical Group | Mission Hills | California | 91345 | United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| North Bay Eye Associates | Petaluma | California | 94954 | United States |
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | United States |
| Danbury Eye Physicians & Surgeons | Danbury | Connecticut | 06810 | United States |
| Shettle Eye Research, Inc. | Largo | Florida | 33773 | United States |
| International Eye Associates, PA | Ormond Beach | Florida | 32174 | United States |
| Dixon Eye Care | Albany | Georgia | 31701-2363 | United States |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | United States |
| Coastal Research Associates, LEC | Roswell | Georgia | 30076 | United States |
| Heart of America Eye Care, P.A. | Shawnee Mission | Kansas | 66204 | United States |
| Tekwani Vision Center | St Louis | Missouri | 63128 | United States |
| Comprehensive Eye Care Ltd | Washington | Missouri | 63090 | United States |
| NYU Langone Health Department of Ophthalmology | New York | New York | 10017 | United States |
| Rochester Ophthalmological Group, PC | Rochester | New York | 14618 | United States |
| South Shore Eye Center | Wantagh | New York | 14618 | United States |
| Asheville Eye Associates, PLLC | Asheville | North Carolina | 28803 | United States |
| Mundorf Eye Center | Charlotte | North Carolina | 28204 | United States |
| Cornerstone Health Care | High Point | North Carolina | 27262 | United States |
| Apex Eye Clinical Research, LLC | Cincinnati | Ohio | 45242 | United States |
| Abrams Eye Center | Cleveland | Ohio | 44115 | United States |
| The Eye Institute | Tulsa | Oklahoma | 74104 | United States |
| Scott & Christie and Associates PC | Cranberry Township | Pennsylvania | 16066-6412 | United States |
| Glaucoma Consultants and Center for Eye Research, PA | Mt. Pleasant | South Carolina | 29464 | United States |
| Total Eye Care PA | Memphis | Tennessee | 38119 | United States |
| VRF Eye Specialty Group | Memphis | Tennessee | 38120 | United States |
| Nashville Vision Associates | Nashville | Tennessee | 37205 | United States |
| Texas Eye, PA | Austin | Texas | 78731 | United States |
| Eye Clinic of Texas | League City | Texas | 77573 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DE-117 Ophthalmic Solution 0.002% | 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. DE-117 Ophthalmic Solution: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set (observed cases only) | Posted | Mean | Standard Deviation | mmHg | Month 3 |
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| Secondary | 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. | Full Analysis Set (observed cases only). | Posted | Mean | Standard Deviation | Percent change | week 2, 6 and month 3 |
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| Secondary | 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). | Full Analysis Set (observed cases only). | Posted | Mean | Standard Deviation | mmHg | week 2 and 6 |
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| Secondary | 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). | Full Analysis Set (observed cases only). | Posted | Mean | Standard Deviation | mmHg | 08:00, 12:00 and 16:00 at Week 2 |
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| Secondary | 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. | Full Analysis Set (observed cases only) | Posted | Mean | Standard Deviation | mmHg | 08:00, 12:00 and 16:00 at Week 6 |
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| Secondary | 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. | Full Analysis Set (observed cases only). | Posted | Mean | Standard Deviation | mmHg | 08:00, 12:00 and 16:00 at month 3 |
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| Secondary | 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. | Full Analysis Set (observed cases only). | Posted | Mean | Standard Deviation | Percent change | 08:00, 12:00 and 16:00 at week 2 |
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| Secondary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | Percent change | 08:00, 12:00 and 16:00 at week 6 |
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| Secondary | 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. | Full Analysis Set (observed cases only). | Posted | Mean | Standard Deviation | Percent change | 08:00, 12:00 and 16:00 at month 3. |
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Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DE-117 Ophthalmic Solution 0.002% | 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. DE-117 Ophthalmic Solution: 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. | 0 | 107 | 0 | 107 | 27 | 107 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Anterior chamber cell | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Conjunctival oedema | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Eyelash hyperpigmentation | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Macular oedema | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Instillation site foreign body sensation | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Instillation site pain | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Suture related complication | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
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| Vital dye staining cornea present | Investigations | MedDRA (21.1) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Subcutaneous abscess | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
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| Cyst | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of R&D Quality Management | Santen Inc | 15106851794 | evelyn.chikere@santen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 8, 2022 | Jun 26, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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