Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease

NCT00717418 | Completed Results

• 1 other identifier: R.E.S.T.O.R.E.
• Study Type: observational
• Target: 781
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Keratoconjunctivitis Sicca

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index (OSDI) Total Score at Baseline

  The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).

  Baseline

Other Outcomes (1)

• Schirmer's Test With and Without Anesthesia at Baseline

  Baseline

Study Arms (1)

1

* cyclosporine ophthalmic emulsion 0.05% * artificial tears

Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears

Interventions

cyclosporine ophthalmic emulsion 0.05%, artificial tears DRUG

one drop, twice a day in each eye

Also known as: Restasis®

1

Eligibility Criteria

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

Study Population

Patients can either: 1. be newly diagnosed or changing therapies and require, in the judgment of the treating physician, a prescription treatment 2. have insufficiently controlled dry eye symptoms necessitating use of over-the-counter treatments

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Wilson, North Carolina, United States

Location

MeSH Terms

Conditions

Keratoconjunctivitis Sicca

Interventions

Cyclosporins; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Limitations and Caveats

Due to actual dry eye treatment used, data were not interpretable by separate treatment arms. Hence, Outcomes are only reported as a single group.

Results Point of Contact

• Title: Vice President, GHOSR
• 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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 17, 2008
• Study Start: September 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2008
• Last Updated: January 12, 2012
• Results First Posted: January 12, 2012

Record last verified: 2011-12

Locations

US (1)