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

Keratoconjunctivitis Sicca Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717418
• Other study ID #: R.E.S.T.O.R.E.
• Status: Completed
• Phase: N/A
• First received: July 14, 2008
• Last updated: December 5, 2011
• Start date: September 2004
• Est. completion date: August 2008

Study information

• Verified date: December 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 781
• Est. completion date: August 2008
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• cyclosporine ophthalmic emulsion 0.05%, artificial tears
one drop, twice a day in each eye

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No