Not Signed In -
Sulfacetamide Ophthalmic |
AK-Sulf; Bleph-10; Cetamide; Isopto Cetamide; Ocusulf-10; Sodium Sulamyd; Sulf-10 |
Clinical Trial: Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients with Moderate to Severe Keratoconjunctivitis Sicca
This study is currently recruiting patients.
Verified by Novartis August 2005
|
Purpose
This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of KCS patients
| Condition | Intervention | Phase |
|---|---|---|
| Keratoconjunctivitis sicca (dry eye syndrome) | Drug: Pimecrolimus | Phase II |
MedlinePlus related topics: Eye Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A 24-Week Randomized, Double-Blind, Multicenter, Parallel-Group, Placebo-Controlled Evaluation of the Safety and Efficacy of 0.3% and 1% Pimecrolimus Ophthalmic Suspensions Used Twice Daily in Patients with Moderate to Severe Keratoconjunctivitis Sicca
Further Study Details:
Study start: September 2004
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- History of artificial tear use
- Moderate to severe signs of dry eye
- Moderate to severe ocular discomfort
Exclusion Criteria:
- Patients with uncontrolled systemic or ocular diseases.
- Have any history of refractive surgery
- Use any topical ocular medications other than those dispensed for the study, during the study
Other protocol-defined exclusion criteria may apply.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00128245
Customer Information Centre 1-800- 862-778-8300
New Jersey
Novartis, East Hanover, New Jersey, United States; Recruiting
Customer Information Centre 862-778-8300
More Information
Study ID Numbers: CASM981E2205
Last Updated: August 8, 2005
Record first received: August 5, 2005
ClinicalTrials.gov Identifier: NCT00128245
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 8, 2005
Record first received: August 5, 2005
ClinicalTrials.gov Identifier: NCT00128245
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
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