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The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-12759 Ophthalmic suspension | Experimental | Instillation, 4times/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-12759 Ophthalmic suspension | Drug | Instillation,4times/day,for 52weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score | FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test). | Baseline, Week2, Week4, Week28, Week52 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score | LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eiji Murakami | OPCJ-DDO | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansai Region | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 2% Rebamipide Group | 2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2% Rebamipide Group | 2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 (CFB) in Fluorescein Corneal Staining (FCS) Score | FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test). | Posted | Mean | Standard Deviation | FCS score | Baseline, Week2, Week4, Week28, Week52 |
|
|
52 Weeks
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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 | 2% Rebamipide Group | 2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | MedDRA(13.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal sensation in eye | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research and Development | Otsuka Pharmaceutical Co., Ltd. | +81-3-6361-7366 |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Baseline, Week2, Week4, Week28, Week52 |
| Kanto Region |
| Japan |
| Kyushu Region | Japan |
| Tohoku Region | Japan |
| Tokai Region | Japan |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Other Pre-specified | Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score | LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test). | Posted | Mean | Standard Deviation | LGCS score | Baseline, Week2, Week4, Week28, Week52 |
|
|
|
|
| 6 |
| 154 |
| 125 |
| 154 |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA(13.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13.0) | Non-systematic Assessment |
|
| Surgical vascular shunt | Surgical and medical procedures | MedDRA(13.0) | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Lacrimation decreased | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Trichiasis | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Meibomian gland discharge | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Dacryostenosis acquired | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Corneal disorder | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Meibomian gland dysfunction | Eye disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA(13.0) | Non-systematic Assessment |
|
| Dacryocystitis | Infections and infestations | MedDRA(13.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA(13.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA(13.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA(13.0) | Non-systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA(13.0) | Non-systematic Assessment |
|
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA(13.0) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA(13.0) | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA(13.0) | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA(13.0) | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA(13.0) | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA(13.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Dysgeusia (bitter taste) | Nervous system disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA(13.0) | Non-systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA(13.0) | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| CFB at Week52 (n=127) |
|
The p value represents the comparison between baseline data and data at Week 4. |
| No |
| Superiority or Other |
| t-test, 2 sided | <0.001 | The p value represents the comparison between baseline data and data at Week 28. | No | Superiority or Other |
| t-test, 2 sided | <0.001 | The p value represents the comparison between baseline data and data at Week 52. | No | Superiority or Other |