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The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. |
|
| 1% OPC-12759 ophthalmic suspension | Experimental | 1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. |
|
| 2% OPC-12759 ophthalmic suspension | Experimental | 2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | comparison of different dosages of drug |
| |
| 1% OPC-12759 ophthalmic suspension |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF) | 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.The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero. | Baseline, 4weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF) | LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctival sac and the conjunctina was divided into 6 ractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-18). 0 is better. The CFB to each study time point was compared between the active-drug groups and the placebo group, and LOCF endpoint scores were used to compare the active-drug groups and the placebo group. In each treatment group, baseline scores and those obtained at each study time point were compared. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Satoshi Oshima | Division of dermatologicals and ophthalmologicals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23009892 | Derived | Kinoshita S, Awamura S, Oshiden K, Nakamichi N, Suzuki H, Yokoi N; Rebamipide Ophthalmic Suspension Phase II Study Group. Rebamipide (OPC-12759) in the treatment of dry eye: a randomized, double-masked, multicenter, placebo-controlled phase II study. Ophthalmology. 2012 Dec;119(12):2471-8. doi: 10.1016/j.ophtha.2012.06.052. Epub 2012 Sep 23. |
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Participant flow results are based on the safety set.
Subjects were recruited in Japan between 2007 and 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | 1% OPC-12759 Groups | 1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks |
| FG001 | 2% OPC-12759 Groups | 2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks |
| FG002 | Placebo | 0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1% OPC-12759 Groups | 1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks |
| BG001 | 2% OPC-12759 Groups | 2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF) | 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.The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero. | Posted | Mean | Standard Deviation | FCS score | Baseline, 4weeks |
|
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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 | 1% OPC-12759 Groups | 1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal sensation in eye | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eiji Murakami | Dermatologicals & Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd. | +81-6-6231-6067 |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Drug |
comparison of different dosages of drug |
|
| 2% OPC-12759 ophthalmic suspension | Drug | comparison of different dosages of drug |
|
| Baseline, 4weeks |
| Kansai Region |
| Japan |
| Kanto Region | Japan |
| Kyushu Region | Japan |
| Shikoku Region | Japan |
| Tohoku Region | Japan |
| BG002 | Placebo | 0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. |
| OG002 | Placebo | 0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. |
|
|
|
| Secondary | Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF) | LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctival sac and the conjunctina was divided into 6 ractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-18). 0 is better. The CFB to each study time point was compared between the active-drug groups and the placebo group, and LOCF endpoint scores were used to compare the active-drug groups and the placebo group. In each treatment group, baseline scores and those obtained at each study time point were compared. | Posted | Mean | Standard Deviation | LGCS score | Baseline, 4weeks |
|
|
|
|
| 0 |
| 103 |
| 30 |
| 103 |
| EG001 | 2% OPC-12759 Groups | 2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks | 0 | 102 | 31 | 102 |
| EG002 | Placebo | 0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks | 1 | 103 | 27 | 103 |
| Blepharitis | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Conjunctivitis allergic | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Corneal erosion | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Episcleritis | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Iritis | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Foreign body sensation in eyes | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Eyelids pruritus | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Dacryostenosis acquired | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Ulcerative keratitis | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Hepatic steatosis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Epiglottitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Blood urea increased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Glucose urine present | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
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