Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00717418

Purpose

This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.

Condition	Intervention
Keratoconjunctivitis Sicca	Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears

MedlinePlus related topics: Eye Diseases

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Further study details as provided by Allergan:

Primary Outcome Measures:

Effectiveness of cyclosporine ophthalmic emulsion 0.05% vs. artificial tears and other non-prescription treatments as assessed by OSDI, Schirmer's Test and Severity Score. [ Time Frame: Assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess quality of life and patient reported outcomes [ Time Frame: Assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	783
Study Start Date:	September 2004
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 - cyclosporine ophthalmic emulsion 0.05% - artificial tears	Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears one drop, twice a day in each eye

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients can either:

be newly diagnosed or changing therapies and require, in the judgment of the treating physician, a prescription treatment
have insufficiently controlled dry eye symptoms necessitating use of over-the-counter treatments

Criteria

Inclusion Criteria:

Diagnosis of dry eye disease
Currently using artificial tears daily
Male or female of legal age of consent
Normal lid position and closure

Exclusion Criteria

Patients currently using cyclosporine ophthalmic emulsion 0.05%
Participation in other investigational drug or device study
Any current or previous topical ophthalmic or oral cyclosporine use within the last three years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717418

Locations

United States, North Carolina

Wilson, North Carolina, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	R.E.S.T.O.R.E.
Study First Received:	July 14, 2008
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00717418 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Corneal Diseases
Cyclosporine
Immunologic Factors
Clotrimazole
Miconazole
Eye Diseases
Tioconazole
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Conjunctivitis

Keratoconjunctivitis
Cyclosporins
Immunosuppressive Agents
Conjunctival Diseases
Xerophthalmia
Antifungal Agents
Keratitis
Antirheumatic Agents
Keratoconjunctivitis Sicca

Additional relevant MeSH terms:

Anti-Infective Agents
Corneal Diseases
Cyclosporine
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Physiological Effects of Drugs
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Enzyme Inhibitors
Conjunctivitis
Immunosuppressive Agents

Keratoconjunctivitis
Cyclosporins
Pharmacologic Actions
Conjunctival Diseases
Xerophthalmia
Therapeutic Uses
Antifungal Agents
Keratitis
Antirheumatic Agents
Dermatologic Agents
Keratoconjunctivitis Sicca

ClinicalTrials.gov processed this record on May 07, 2009