Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%

NCT00827255 | Completed Results

• 1 other identifier: MA-RES-08-002
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this retrospective chart review is to evaluate the patient characteristics, treatment variations and efficacy of a second trial of Cyclosporine Ophthalmic Emulsion 0.05% therapy in chronic dry eye patients who were initially treated with Cyclosporine Ophthalmic Emulsion 0.05% but discontinued use after less than 12 weeks of treatment.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Complete Clearing of Corneal Staining at Month 12

  Percentage of patients with complete clearing of corneal staining at month 12. Corneal staining is evaluated following administration of fluorescein dye into the eye. Complete clearing is defined as the absence of corneal staining.

  Month 12

Secondary Outcomes (1)

• Schirmer's Test at Month 12

  Month 12

Study Arms (1)

Patients who received Restasis®

Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)

Drug: Cyclosporine Ophthalmic Emulsion 0.05%

Interventions

Cyclosporine Ophthalmic Emulsion 0.05% DRUG

One drop two times a day approximately 12 hours apart

Also known as: RESTASIS®

Patients who received Restasis®

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The medical charts of all chronic dry eye patients who discontinued their first trial of RESTASIS® after less than 12 weeks of treatment and who started a second trial of RESTASIS® prior to June 1, 2008 will be included in the review.

You may qualify if:

• Adults \>16 years of age
• Dry eye patients
• Subject with history of less than 12 weeks of initial RESTASIS® treatment
• Subject started second trial of RESTASIS® treatment prior to June 1, 2008
• First day of second trial of RESTASIS® started ≥ 4 weeks after the last day of previous RESTASIS® treatment

You may not qualify if:

• Patients with Contact Lens Intolerance
• Patients with Ocular Rosacea

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Related Publications (1)

• Mah F, Milner M, Yiu S, Donnenfeld E, Conway TM, Hollander DA. PERSIST: Physician's Evaluation of Restasis((R)) Satisfaction in Second Trial of topical cyclosporine ophthalmic emulsion 0.05% for dry eye: a retrospective review. Clin Ophthalmol. 2012;6:1971-6. doi: 10.2147/OPTH.S30261. Epub 2012 Nov 28.

  PMID: 23226002 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Vice President, Medical Affairs
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 22, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 25, 2019
• Results First Posted: July 18, 2012

Record last verified: 2019-04

Locations

US (1)