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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-050040 |
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The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5% OPC-12759 | Experimental | 0.5% OPC-12759 (rebamipide) ophthalmic suspension |
|
| 1% OPC-12759 | Experimental | 1% OPC-12759 (rebamipide) ophthalmic suspension |
|
| 2% OPC-12759 | Experimental | 2% OPC-12759 (rebamipide) ophthalmic suspension |
|
| placebo | Placebo Comparator | placebo of OPC-12759 (rebamipide) ophthalmic suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% OPC-12759 | Drug |
| ||
| 1% OPC-12759 |
| 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, 12 weeks |
| Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF) | POD indicates the ocular symptom most bothersome to the patient. POD selected by each patient from among the following ocular symptoms; Foreign body sensation, Dryness, Photophobia, Eye pain and Blurred vision. POD was scored from 0 through 4; a score of 0 indicated no symptoms and a score of 4 indicated very severe symptoms. 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, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Satoshi Oshima | Dermatologicals & Ophthalmologicals Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otsuka Pharmaceutical Co., Ltd. | Tokyo | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.5% OPC-12759 | 0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks |
| FG001 | 1% OPC-12759 | 1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks |
| FG002 | 2% OPC-12759 | 2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks |
| FG003 | Placebo | 0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.5% OPC-12759 | 0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks |
| BG001 | 1% OPC-12759 | 1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 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 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 | scores on a scale | baseline, 12 weeks |
|
12 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 | 0.5% OPC-12759 | 0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharitis | Eye disorders | MedDRA (8.1) | 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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| ID | Term |
|---|---|
| C052785 | rebamipide |
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|
| 2% OPC-12759 | Drug |
|
| placebo | Drug |
|
| BG002 | 2% OPC-12759 | 2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks |
| BG003 | Placebo | 0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks |
| OG002 | 2% OPC-12759 | 2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks |
| OG003 | Placebo | 0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks |
|
|
|
| Primary | Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF) | POD indicates the ocular symptom most bothersome to the patient. POD selected by each patient from among the following ocular symptoms; Foreign body sensation, Dryness, Photophobia, Eye pain and Blurred vision. POD was scored from 0 through 4; a score of 0 indicated no symptoms and a score of 4 indicated very severe symptoms. 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 | scores on a scale | Baseline, 12 weeks |
|
|
|
|
| Post-Hoc | Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Week 12 | 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 CFB in the FCS scores were compared between the 0.5, 1 and 2% rebamipide group and the placebo group using a Dunnett's t-test | From the FAS of 290 patients, 218 patients who had no punctal plug insertion or punctal occlusion and who had a baseline schirmer test value of equal to or less than 5 mm for the eye evaluated for efficacy were selected and subjected to exploratory data analysis | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 12week |
|
|
|
|
| Post-Hoc | Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Week 12 | 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. The CFB in the LGCS scores were compared between the 0.5, 1 and 2% rebamipide group and the placebo group using a Dunnett's t-test. | From the FAS of 290 patients, 218 patients who had no punctal plug insertion or punctal occlusion and who had a baseline schirmer test value of equal to or less than 5 mm for the eye evaluated for efficacy were selected and subjected to exploratory data analysis | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 12weeks |
|
|
|
|
| 1 |
| 72 |
| 32 |
| 72 |
| EG001 | 1% OPC-12759 | 1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks | 0 | 72 | 29 | 72 |
| EG002 | 2% OPC-12759 | 2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks | 2 | 74 | 43 | 74 |
| EG003 | Placebo | 0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks | 2 | 72 | 23 | 72 |
| Dislocation of joint prosthesis | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
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| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | Non-systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Eyelid oedema | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA (8.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Dysgeusia (bitter taste) | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
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p-value is adjusted for multiple comparisons |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.421 | p-value is adjusted for multiple comparisons | No | Superiority or Other |
p-value is adjusted for multiple comparisons |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.029 | p-value is adjusted for multiple comparisons | No | Superiority or Other |