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OpenTrials
Completed

NCT Number: NCT00405457

Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.

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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

Minnesota Eye Consultants

Minneapolis, Minnesota, 55404, 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
  • Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye.
  • Likely to complete all study visits and able to provide informed consent

Exclusion criteria

  • · Patients using Restasis® for less than 3 months.
  • 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.
  • Other active uncontrolled ocular diseases or uncontrolled systemic disease

Treatment and study plan

Restasis, Optive Tears

Drug

Restasis and Optive Tears use twice daily more frequently if needed

Primary outcomes

  1. efficacy

    Time frame: 1 yr 3 months

Secondary outcomes

  1. dry eye symptoms

    Time frame: 1 yr 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 30, 2006
Registry last updated
Feb 22, 2010

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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