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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-111708 | Other Identifier | Japic |
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The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-12759 is to be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-12759 ophthalmic suspension | Experimental | OPC-12759 ophthalmic suspension |
|
| Sodium hyaluronate ophthalmic solution | Active Comparator | Sodium hyaluronate ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-12759 ophthalmic suspension | Drug | OPC-12759 ophthalmic suspension 2% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Keratoconjunctival Staining Score From Baseline | Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, 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 at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test. | Basekine, 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eiji Murakami | Division Dermatilogicals and Ophtalmolgicals, Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanto region | Hachiōji | Japan | ||||
| Kansai region |
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| ID | Title | Description |
|---|---|---|
| FG000 | OPC-12759 Ophthalmic Suspension | OPC-12759 ophthalmic suspension 2% |
| FG001 | Sodium Hyaluronate Ophthalmic Solution | Sodium hyaluronate ophthalmic solution 0.1% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OPC-12759 Ophthalmic Suspension | OPC-12759 ophthalmic suspension 2% |
| BG001 | Sodium Hyaluronate Ophthalmic Solution | Sodium hyaluronate 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, 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 the Keratoconjunctival Staining Score From Baseline | Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, 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 at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test. | Posted | Mean | Standard Deviation | scores on a scale | Basekine, 4 weeks |
|
4 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 | OPC-12759 Ophthalmic Suspension | OPC-12759 ophthalmic suspension 2% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meningitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chalazion | Eye disorders | MedDRA (15.0) | 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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| Sodium hyaluronate ophthalmic solution | Drug | Sodium hyaluronate ophthalmic solution 0.1% |
|
| Ibaraki |
| Japan |
| Kansai region | Ikoma | Japan |
| Kansai Region | Kobe | Japan |
| Chugoku region | Kure | Japan |
| Kansai region | Kyoto | Japan |
| Tokai region | Nagoya | Japan |
| Kansai region | Osaka | Japan |
| Kansai region | Sayama | Japan |
| Kanto region | Tokyo | Japan |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Sodium hyaluronate ophthalmic solution 0.1%
|
|
|
| 1 |
| 51 |
| 16 |
| 51 |
| EG001 | Sodium Hyaluronate Ophthalmic Solution | Sodium hyaluronate ophthalmic solution 0.1% | 0 | 51 | 12 | 51 |
| Conjunctivitis | Eye disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Corneal deposits | Eye disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Corneal infiltrates | Eye disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Keratitis | Eye disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Trichiasis | Eye disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
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| Blood urea increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Dysgeusia (bitter taste) | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Vocal cord inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
|
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