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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-121920 | Other Identifier | JapicCTI |
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The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a reference drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-12759 ophthalmic solution | Experimental | OPC-12759 ophthalmic solution |
|
| Placebo | Placebo Comparator | OPC-12759 ophthalmic solution 0% |
|
| OPC-12759 ophthalmic suspension | Active Comparator | OPC-12759 ophthalmic suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-12759 | Drug | Instillation, 4 times/day for 4 weeks |
|
| 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. Changes of the FCS score from baseline to the last dose (last observation carried forward [LOCF]) were compared between 2% OPC-12759 ophthalmic solution and placebo by the t-test. | Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 score from 0 to 3, and the total score was calculated (0-18). 0 is better. The scores and change from baseline at each examination (including LOCF) were compared between 2% OPC-12759 ophthalmic solution and placebo ophthalmic solution. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eiji Murakami | Director of Division Dermatilogicals and Ophtalmolgicals, Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansai Region | Kansai Region | Japan | ||||
| Kanto region |
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| ID | Title | Description |
|---|---|---|
| FG000 | OPC-12759 Solution | One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks. |
| FG001 | Placebo | One drop of 0% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks. |
| FG002 | OPC-12759 Suspension | One drop of 2% OPC-12759 ophthalmic suspension was instilled into each eye 4 times a day for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OPC-12759 Solution | One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks. |
| BG001 | Placebo | One drop of 0% OPC-12759 ophthalmic solution was instilled into each eye 4 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, 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 | 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. Changes of the FCS score from baseline to the last dose (last observation carried forward [LOCF]) were compared between 2% OPC-12759 ophthalmic solution and placebo by the t-test. | Full analysis set consisted of all subjects who had received the investigational product at least once after randomized assignment to a treatment group. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 4 |
|
Treatment period (4 weeks)
Only adverse events that occurred after the start of study treatment were evaluated.
Safety analysis set consisted of all subjects who had received the investigational product at least once.
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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 | OPC-12759 Solution | One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal sensation in eye | Eye disorders | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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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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| Placebo | Drug |
|
| Baseline, Week 4 |
| Kanto Region |
| Japan |
| Kyushu region | Kyushu Region | Japan |
| Tokai region | Tokai Region | Japan |
| BG002 | OPC-12759 Suspension | One drop of 2% OPC-12759 ophthalmic suspension was instilled into each eye 4 times a day for 4 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Placebo | One drop of 0% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks. |
| OG002 | OPC-12759 Suspension | One drop of 2% OPC-12759 ophthalmic suspension was instilled into each eye 4 times a day for 4 weeks. |
|
|
|
| Secondary | 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 score from 0 to 3, and the total score was calculated (0-18). 0 is better. The scores and change from baseline at each examination (including LOCF) were compared between 2% OPC-12759 ophthalmic solution and placebo ophthalmic solution. | Full analysis set consisted of all subjects who had received the investigational product at least once after randomized assignment to a treatment group. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 4 |
|
|
|
|
| 0 |
| 84 |
| 0 |
| 84 |
| 23 |
| 84 |
| EG001 | Placebo | One drop of 0% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks. | 0 | 83 | 0 | 83 | 11 | 83 |
| EG002 | OPC-12759 Suspension | One drop of 2% OPC-12759 ophthalmic suspension was instilled into each eye 4 times a day for 4 weeks. | 0 | 42 | 0 | 42 | 11 | 42 |
| Eye irritation | Eye disorders | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Ulcerative keratitis | Eye disorders | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Periproctitis | Gastrointestinal disorders | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Adenoviral conjunctivitis | Infections and infestations | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Blood urea increased | Investigations | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Glucose urine present | Investigations | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Protein urine present | Investigations | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 15.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA Ver. 15.0 | Non-systematic Assessment |
|
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