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This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cyclosporine ophthalmic emulsion 0.05% | Experimental | One drop in the study eye (or eyes) administered four times daily (QID) |
|
| Vehicle | Placebo Comparator | One drop in the study eye (or eyes) administered four times daily (QID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine ophthalmic emulsion 0.05% | Drug | One drop in the study eye (or eyes) administered four times daily (QID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Pterygium Hyperemia Responders at Week 16 | Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia. | Week 16 |
| Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16 | Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16 | Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | California | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyclosporine Ophthalmic Emulsion 0.05% | One drop in the study eye (or eyes) administered four times daily (QID) |
| FG001 | Vehicle | One drop in the study eye (or eyes) administered four times daily (QID) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyclosporine Ophthalmic Emulsion 0.05% | One drop in the study eye (or eyes) administered four times daily (QID) |
| BG001 | Vehicle | One drop in the study eye (or eyes) administered four times daily (QID) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Pterygium Hyperemia Responders at Week 16 | Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia. | Modified Intent to Treat: All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia | Posted | Number | Participants | Week 16 |
|
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The Safety Population was used to calculate the number of participants at risk for SAEs and AEs, and is defined as all randomized and treated patients.
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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 | Cyclosporine Ophthalmic Emulsion 0.05% | One drop in the study eye (or eyes) administered four times daily (QID) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Irritation | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D011625 | Pterygium |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| Vehicle | Drug | One drop in the study eye (or eyes) administered four times daily (QID) |
|
| Baseline, Week 16 |
| Randwick |
| New South Wales |
| Australia |
| Singapore | Singapore |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Vehicle |
One drop in the study eye (or eyes) administered four times daily (QID) |
|
|
| Primary | Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16 | Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening. | Modified Intent to Treat: All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 16 |
|
|
|
| Secondary | Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16 | Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement. | Modified Intent to Treat: All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 16 |
|
|
|
| 1 |
| 56 |
| 19 |
| 56 |
| EG001 | Vehicle | One drop in the study eye (or eyes) administered four times daily (QID) | 1 | 58 | 16 | 58 |
| Meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 14.0 | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Eye Pain | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
|
| Instillation Site Pain | General disorders | MedDRA version 14.0 | Non-systematic Assessment |
|
| Lacrimation Increased | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
|
| Ovarian Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 14.0 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D000602 |
| Amino Acids, Peptides, and Proteins |