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The purpose of this study is to investigate the intraocular pressure-lowering effect and the safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in subjects with open angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DE-117 ophthalmic solution | Experimental |
| |
| Latanoprost ophthalmic solution 0.005% | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-117 | Drug | DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Diurnal IOP at Month 3 | The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject. | Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00) |
| Measure | Description | Time Frame |
|---|---|---|
| IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject. | 09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | DE-117 Ophthalmic Solution | DE-117: DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes. |
| FG001 | Latanoprost Ophthalmic Solution 0.005% | Latanoprost ophthalmic solution: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes. |
| 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 | Jun 28, 2016 | Jul 27, 2023 |
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| Latanoprost ophthalmic solution | Drug | Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes. |
|
|
| Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint) | The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject. | Week 1 |
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| NOT COMPLETED |
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All 370 subjects received at least 1 dose of their assigned study medication and were included in the Safety population. Data for all subjects except 1 were included in the Full Analysis Set (FAS); 1 subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement.
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| ID | Title | Description |
|---|---|---|
| BG000 | DE-117 Ophthalmic Solution | DE-117: DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes. |
| BG001 | Latanoprost Ophthalmic Solution 0.005% | Latanoprost ophthalmic solution: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes. |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| 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 | Mean Diurnal IOP at Month 3 | The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject. | One subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement. | Posted | Least Squares Mean | Standard Error | mmHg | Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00) |
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| Secondary | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject. | One subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement. | Posted | Least Squares Mean | Standard Error | mmHg | 09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3. |
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| |||||||||||||||||||||||||||||
| Secondary | Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint) | The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject. | One subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement. | Posted | Least Squares Mean | Standard Error | mmHg | Week 1 |
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An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization.
Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
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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 | DE-117: DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes. | 0 | 185 | 2 | 185 | 74 | 185 |
| EG001 | Latanoprost Ophthalmic Solution 0.005% | Latanoprost ophthalmic solution: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes. | 0 | 185 | 2 | 185 | 55 | 185 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
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| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Corneal thickening | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Conjunctival irritation | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Corneal deposits | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Corneal pigmentation | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eyelid irritation | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eyelids pruritus | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Conjunctival follicles | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Corneal erosion | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Corneal opacity | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eyelid oedema | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Foreign body sensation in eyes | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Iritis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Noninfective conjunctivitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Blepharal pigmentation | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eyelash thickening | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Growth of eyelashes | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Gastroduodenitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Allergy to arthropod sting | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Stoma site infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Optic nerve cup/disc ratio increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Vital dye staining cornea present | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Low density lipoprotein increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Spondyloarthropathy | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
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| Breast calcifications | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | 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 12, 2019 | Jul 27, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| South Korea |
|
| Singapore |
|
| Taiwan |
|
|
|