Atopic Conjunctivitis Clinical Trial
| Verified date | November 2012 |
| Source | Allergan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 176 |
| Est. completion date | July 2011 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: - Have a clinical diagnosis of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye) - Be on stable doses of your current AKC medications for at least 2 weeks Exclusion Criteria: - You have used contact lenses within 48 hours of Day 1 or think you may have to wear contact lenses during the study - You are pregnant, breastfeeding, or planning to become pregnant during the study - You have used a calcineurin inhibitors (e.g. topical tacrolimus or topical pimecrolimus) on or around your eyes including eyelids within 4 weeks |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Allergan |
United States, Australia, Canada, Czech Republic, France, Germany, India, Israel, Italy, New Zealand, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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). | Baseline, Month 2 | No |
| 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. | Month 2 | No |
| 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. | Baseline, Month 2 | No |
| 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. | Baseline, Month 2 | No |