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Completed

NCT Number: NCT00717418

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Wilson, North Carolina, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cyclosporine ophthalmic emulsion 0.05%, artificial tears

Drug

one drop, twice a day in each eye

Other names: Restasis®

Primary outcomes

  1. Ocular Surface Disease Index (OSDI) Total Score at Baseline

    Time frame: 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).

Other outcomes

  1. Schirmer's Test With and Without Anesthesia at Baseline

    Time frame: Baseline

    Schirmer's Test with and without anesthesia at baseline. The Schirmer's test is performed on each eye with and without anesthesia (numbing eye drop). The amount of wetting produced by the eye was measured in millimeters using a graduated paper scale. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm), Dry eye = less than 15 mm). A larger number correlates to better tear production, a smaller number correlates to reduced tear production.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2008
First posted
Jul 17, 2008
Registry last updated
Jan 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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