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The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rebamipide | Experimental | Instillation,4 times/day for 4 weeks |
|
| Hyaluronate | Active Comparator | Instillation,6 times/day for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-12759 Ophthalmic suspension | Drug | OPC-12759 Ophthalmic suspension 2% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fluorescein Corneal Staining (FCS) Score From Baseline | 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. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups | Baseline, Weeks4 |
| Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline | 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 sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups. | Baseline, Weeks4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eiji Murakami | OPCJ-DDO | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyushu region | Kagoshima | Japan | ||||
| Chushikoku region |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rebamipide | Instillation,4 times/day for 4 weeks OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2% |
| FG001 | Hyaluronate | Instillation,6 times/day for 4 weeks Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rebamipide | Instillation,4 times/day for 4 weeks OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2% |
| BG001 | Hyaluronate | Instillation,6 times/day for 4 weeks Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1% |
| 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 | 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. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks4 |
|
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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 | Rebamipide | Instillation,4 times/day for 4 weeks OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharitis | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr. Kyoji Imaoka | Otsuka Pharmaceutical Co., Ltd. | -81-6-6943-7722 |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Hyalein Mini Ophthalmic solution |
| Drug |
Hyalein Mini Ophthalmic solution 0.1% |
|
| Matsuyama |
| Japan |
| Tokai region | Nagoya | Japan |
| Kansai region | Osaka | Japan |
| Kanto region | Tokyo | Japan |
| BG002 | 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 |
|
Instillation,6 times/day for 4 weeks Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1% |
|
|
|
| Primary | Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline | 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 sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks4 |
|
|
|
|
| 0 |
| 93 |
| 27 |
| 93 |
| EG001 | Hyaluronate | Instillation,6 times/day for 4 weeks Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1% | 0 | 95 | 19 | 95 |
| Chalazion | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Erythema of eyelid | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Eyelid oedema | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA (12.1) | Systematic Assessment |
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| Thirst | General disorders | MedDRA (12.1) | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Onychomycosis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (12.1) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA (12.1) | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA (12.1) | Systematic Assessment |
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| Blood urea increased | Investigations | MedDRA (12.1) | Systematic Assessment |
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| Blood urine present | Investigations | MedDRA (12.1) | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
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| Dysgeusia (bitter taste) | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
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