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OpenTrials
Completed

NCT Number: NCT00399061

Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms

The purpose of this study is to evaluate the efficacy of Optive versus Systane used concomitantly with topical cyclosporine for the treatment of dry eye.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr. Schultze

Slingerlands, New York, 12159, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • · Males or females > 18 years old
  • Score of at least 2 and no more than 4 on the SESOD at the initial screening visit (mild to severe patients)
  • At least Grade 2 conjunctival staining
  • Likely to complete all study visits and able to provide informed consent

Exclusion criteria

  • · Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months and saw no improvements)
  • Current use of topical cyclosporine
  • Known contraindications to any study medication or ingredients
  • Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
  • Planned use of contact lenses (unless discontinued use ³ 30 days prior to randomization)
  • Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
  • Ocular surgery within the past 3 months,
  • Active ocular allergies

Treatment and study plan

Systane, Optive, Restasis

Drug

Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed

Primary outcomes

  1. Efficacy

    Time frame: 1 yr 3 months

Secondary outcomes

  1. Dry eye symptoms

    Time frame: 1yr 3 months

Sponsors and collaborators

Lead sponsor

Innovative Medical

Industry

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 14, 2006
Registry last updated
Sep 25, 2008

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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