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Completed

NCT Number: NCT00706940

Tear Dynamics After Restasis Treatment in Dry Eye Patients

Observe the changes of tear volume in dry eye patients after Restasis treatment of 3 months and during 6-month follow-up after discontinuation of study treatment.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

About this study

Using an imaging device name optical coherence tomography to image the tear volume in dry eye patients before and after Restasis treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The participant will be eligible for entry in the study if s/he:

  • Is at least 18 years old and has full legal capacity to volunteer;
  • Has read and signed the IRB Informed Consent Document;
  • Is willing and able to follow participant instructions;
  • Has clear corneas;
  • Has 20/100 uncorrected visual acuity or better;
  • Has dry eye according to the study definition of DES (study subjects);
  • Has not use Restasis within 3 months.

Exclusion criteria

The subjects will ineligible for entry into the study if s/he:

  • Has any systemic disease affecting ocular health except for Sjögren's syndrome;
  • Is using any systemic or topical medications that will affect ocular health except for artificial tears;
  • Has an active ocular disease other than DES, or Sjögren's syndrome
  • Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
  • Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES;
  • Has worn rigid gas permeable lenses within 1 year and during the study;
  • Has had surgery or an eye injury within 6 months;
  • Was a soft contact lens wearer within 2 weeks and during the study.

Treatment and study plan

Primary outcomes

  1. Increase in tear volume after the 3-month treatment and returned to baseline during 6-month follow-up after discontinuation of study treatment.

    Time frame: 3 months for treatment and follow-up of 6 months after discontinuation of study treatment.

  2. Tear meniscus volume after treatment

    Time frame: 3 months

    Significant increase in tear meniscus volume was found in patients after 3 months of treatment.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Allergan

Registry information

Official study title

Tear Dynamics After Restasis Treatment in Dry Eye Patients Phase II Clinical Trial and Phase IIb 6-month Follow-up After Discontinuation of Study Treatment

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jun 30, 2008
Registry last updated
Apr 25, 2017

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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