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This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. For the first 3 months of the study, patients will receive either masked Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients who are in remission, will be re-randomized to receive either open-labeled Cyclosporine 0.010% eye drops four times daily or twice daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporine Ophthalmic Solution (COS) followed by COS | Experimental | Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. |
|
| Placebo followed by COS | Other | Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine Vehicle | Drug | Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Treatment Responders | Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is >316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0 to 15) is the sum of 5 symptoms (each symptom is assessed on a scale of 0=absent to 3=severe). | Baseline, Month 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Punctate Corneal Staining Responders | Punctate corneal staining responders defined as patients achieving a punctate corneal staining score of 0 or 1 in the study eye. Punctate corneal staining is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion. |
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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 |
|---|---|---|---|---|---|---|
| Bakersfield | California | United States | ||||
Per protocol defined pre-specified criteria, both eyes could qualify for treatment. However, only one eye was designated as the study eye.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyclosporine Ophthalmic Solution (COS) Followed by COS | Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. |
| FG001 | Placebo Followed by COS | Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-Masked Phase (Day 1-Month 3) |
| |||||||||||||
| Open-Label Phase (Months 3-9) |
| |||||||||||||
| Open-Label Maintenance (Months 9-12) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyclosporine Ophthalmic Solution (COS) Followed by COS | Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. |
| BG001 | Placebo Followed by COS |
| 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 | Percentage of Treatment Responders | Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is >316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0 to 15) is the sum of 5 symptoms (each symptom is assessed on a scale of 0=absent to 3=severe). | Intent to Treat: all randomized patients | Posted | Number | Percentage of Patients | Baseline, Month 2 |
|
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The Safety Population was used for all adverse event (AE)/serious adverse event (SAE) reporting. All patients in the safety population received at least 1 dose of study medication.
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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 Solution (COS) Followed by COS | Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Forearm Fracture | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Keratitis | Eye disorders | MedDRA version 10.0 | 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 |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Cyclosporine 0.010% | Drug | Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. |
|
| Month 2 |
| Percentage of Patients With an Improvement in the Composite Symptom Score | Composite symptom score improvement is defined as a 4 or more grade decrease from baseline in composite symptom score in the study eye. The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). Each of the 5 symptoms is assessed on a scale of 0=absent to 3=severe. The composite symptom score is the sum of all 5 individual symptom scores, where 0 is no symptoms and 15 is the most severe symptoms. | Baseline, Month 2 |
| Percentage of Patients With an Improvement in the Punctate Corneal Staining Score | Punctate corneal staining improvement is defined as a 1 or more grade decrease from baseline in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion. | Baseline, Month 2 |
| Randwick |
| New South Wales |
| Australia |
| Ottawa | Ontario | Canada |
| Prague | Czechia |
| Dijon | Burgundy | France |
| Munich | Bavaria | Germany |
| Bangalore | Karnataka | India |
| Tel Aviv | Israel |
| Rome | Italy |
| Wellington | New Zealand |
| Valladolid | Spain |
| Newcastle upon Tyne | Tyne and Wear | United Kingdom |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months. |
|
|
| Secondary | Percentage of Punctate Corneal Staining Responders | Punctate corneal staining responders defined as patients achieving a punctate corneal staining score of 0 or 1 in the study eye. Punctate corneal staining is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion. | Intent to Treat: all randomized patients | Posted | Number | Percentage of Patients | Month 2 |
|
|
|
| Secondary | Percentage of Patients With an Improvement in the Composite Symptom Score | Composite symptom score improvement is defined as a 4 or more grade decrease from baseline in composite symptom score in the study eye. The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). Each of the 5 symptoms is assessed on a scale of 0=absent to 3=severe. The composite symptom score is the sum of all 5 individual symptom scores, where 0 is no symptoms and 15 is the most severe symptoms. | Intent to Treat: all randomized patients | Posted | Number | Percentage of Patients | Baseline, Month 2 |
|
|
|
| Secondary | Percentage of Patients With an Improvement in the Punctate Corneal Staining Score | Punctate corneal staining improvement is defined as a 1 or more grade decrease from baseline in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion. | Posted | Number | Percentage of Patients | Baseline, Month 2 |
|
|
|
| 11 |
| 171 |
| 44 |
| 171 |
| EG001 | Placebo | Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months. | 3 | 87 | 16 | 87 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Anaphylactic Shock | Immune system disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Infectious Mononucleosis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
|
| Prostatic Specific Antigen Increased | Investigations | MedDRA version 10.0 | Systematic Assessment |
|
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
|
| Abdominal Hernia | Gastrointestinal disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 10.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Joint Injury | Injury, poisoning and procedural complications | MedDRA version 10.0 | Non-systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA version 10.0 | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Punctate Keratitis | Eye disorders | MedDRA version 10.0 | 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.
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |