Comparison of Efficacy, Safety and Anti-Inflammatory Effect Between Topical 0.05%Cyclosporine A Emulsion and REFRESH® in Patients With Moderate to Severe Dry Eyes
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Chulalongkorn University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Chulalongkorn University
Collaborator:
Allergan
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00704275
First received: June 20, 2008
Last updated: June 23, 2008
Last verified: June 2008
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Purpose
To compare the efficacy, safety and tolerability of 0.05% topical cyclosporin eye drop to Refresh in moderate to severe dry eye patients. Null hypothesis is: there is no difference between these two groups.
| Condition | Intervention | Phase |
|---|---|---|
|
Dry Eye |
Drug: 0.05% cyclosporin eye drop |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Efficacy, Safety and Anti-Inflammatory Effect Between Topical 0.05%Cyclosporine A Emulsion and REFRESH® in Patients With Moderate to Severe Dry Eyes |
Resource links provided by NLM:
Genetics Home Reference related topics:
keratitis-ichthyosis-deafness syndrome
Drug Information available for:
Cyclosporine
U.S. FDA Resources
Further study details as provided by Chulalongkorn University:
Primary Outcome Measures:
- Corneal and conjunctival staining score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Schirmer 1 score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | October 2008 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
0.05% cyclosporin
|
Drug: 0.05% cyclosporin eye drop
bid dosage for 4 months
|
|
Active Comparator: B
Refresh
|
Drug: 0.05% cyclosporin eye drop
bid dosage for 4 months
|
Detailed Description:
Inclusion criteria:
- Participants are moderate to severe dry eye patients aged more than 18 years of age
- Oxford staining scores of more than five.
- OSDI scores of more than 0.1
Outcome measurements:
Main parameter is staining score (corneal + conjunctival) Other parameter is OSDI score, symptom of ocular surface discomfort score, number of daily artificial tear needed, TBUT, Schirmer I score, cytokines level & markers Safety parameters: VA, IOP, cyclosporin level
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- moderate to severe dry eye
Exclusion Criteria:
- lid anomaly, previous CsA use
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704275
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704275
Contacts
| Contact: Vilavun Puangsricharern, MD | 66-2256-4424 | vilavun@hotmail.com | |
| Contact: Anyanee Charoensri, MD | 66-8464-70202 | anyaneeam@yahoo.com |
Locations
| Thailand | |
| OPD Chulalongkorn University Hospital | Active, not recruiting |
| Bangkok, Thailand, 10330 | |
| OPD Chulalongkorn University Hospital | Recruiting |
| Bangkok, Thailand | |
| Contact: Vilavun Puangsricharern, MD | |
Sponsors and Collaborators
Chulalongkorn University
Allergan
More Information
| Responsible Party: | Vilavun Puangsricharern/Ass. Prof in Ophthalmology, Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University |
| ClinicalTrials.gov Identifier: | NCT00704275 History of Changes |
| Other Study ID Numbers: | 391/48 |
| Study First Received: | June 20, 2008 |
| Last Updated: | June 23, 2008 |
| Health Authority: | Thailand: Khon Kaen University Ethics Committee for Human Research |
Keywords provided by Chulalongkorn University:
|
dry eye |
Additional relevant MeSH terms:
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Cyclosporins Cyclosporine Ophthalmic Solutions |
Anti-Inflammatory Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents Calcineurin Inhibitors Pharmaceutical Solutions |
ClinicalTrials.gov processed this record on September 28, 2016