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
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ClinicalTrials.gov Identifier: NCT00704275 |
Recruitment Status
: Unknown
Verified June 2008 by Chulalongkorn University.
Recruitment status was: Recruiting
First Posted
: June 24, 2008
Last Update Posted
: June 24, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye | Drug: 0.05% cyclosporin eye drop | Phase 4 |
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
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | June 2007 |
Estimated Primary Completion Date : | July 2008 |
Estimated Study Completion Date : | October 2008 |

Arm | Intervention/treatment |
---|---|
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
|
- Corneal and conjunctival staining score [ Time Frame: 1 year ]
- Schirmer 1 score [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- moderate to severe dry eye
Exclusion Criteria:
- lid anomaly, previous CsA use

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704275
Contact: Vilavun Puangsricharern, MD | 66-2256-4424 | vilavun@hotmail.com | |
Contact: Anyanee Charoensri, MD | 66-8464-70202 | anyaneeam@yahoo.com |
Thailand | |
OPD Chulalongkorn University Hospital | Active, not recruiting |
Bangkok, Thailand, 10330 | |
OPD Chulalongkorn University Hospital | Recruiting |
Bangkok, Thailand | |
Contact: Vilavun Puangsricharern, MD |
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 |
First Posted: | June 24, 2008 Key Record Dates |
Last Update Posted: | June 24, 2008 |
Last Verified: | June 2008 |
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 |
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 |