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Diurnal Variation of Tear Meniscus and Tear Osmolarity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Miami.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Allergan
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT01206244
First received: September 20, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

This study is to determine the diurnal variation of tear meniscus and tear osmolarity in normal subjects and dry eye patients.


Condition
Dry Eye

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Diurnal Variation of Tear Meniscus and Tear Osmolarity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Miami:

Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal
Normal subjects
Dry eye
clinically diagnosed dry eye with aqueous tear deficiency

Detailed Description:

This study is to determine the diurnal variation of tear meniscus using OCT and tear osmolarity using Tearlab's osmolarity system in normal subjects and dry eye patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Normal subjects vs. dry eye patients

Criteria

Inclusion criteria

  1. Is at least 18 years old and has full legal capacity to volunteer;
  2. Has read and signed the IRB Informed Consent Document;
  3. Is willing and able to follow participant instructions;
  4. Has clear corneas;
  5. Has 20/100 uncorrected visual acuity or better;
  6. Is not a hard (or rigid gas permeable) contact lens wearer within the last year;
  7. Was a soft contact lens wearer, but stopped wearing at least 1 week ago;
  8. Has dry eye according to the study definition of DES (study subjects).

Exclusion criteria

  1. Has any systemic disease affecting ocular health except for Sjögren's syndrome;
  2. Is using any systemic or topical medications that will affect ocular health except for artificial tears;
  3. Has an active ocular disease other than DES, meibomian gland disease or Sjögren's syndrome
  4. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
  5. Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES;
  6. Has worn rigid gas permeable lenses within 1 year;
  7. Has had surgery or an eye injury within 6 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206244

Locations
United States, Florida
Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Jianhua Wang, MD, PhD     305-482-5010     jwang3@med.miami.edu    
Principal Investigator: Jianhua Wang, MD, PhD            
Sponsors and Collaborators
University of Miami
Allergan
Investigators
Principal Investigator: Jianhua Wang, MD, PhD University of Miami
  More Information

No publications provided

Responsible Party: Jianhua Wang, MD, PhD, University of Miami
ClinicalTrials.gov Identifier: NCT01206244     History of Changes
Other Study ID Numbers: UM20100465
Study First Received: September 20, 2010
Last Updated: September 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
dry eye
tear meniscus
tear osmolarity

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on May 16, 2013