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Tear Osmolarity Over Time With Artificial Tears

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Allergan
Information provided by:
Hom, Milton M., OD, FAAO
ClinicalTrials.gov Identifier:
NCT01227226
First received: October 21, 2010
Last updated: February 4, 2011
Last verified: February 2011
History of Changes
  Purpose

The effect of artificial tears on tear osmolarity


Condition Intervention Phase
Dry Eye
 Drug: Artificial tears
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hom, Milton M., OD, FAAO:

Primary Outcome Measures:
  • Tear osmolarity [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Tear osmolarity measured with TearLab instrument


Estimated Enrollment: 48
Study Start Date: October 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Refresh tears
Allergan's Refresh tears artificial tear
 Drug: Artificial tears
Instill one drop of artificial tears
Other Name: Allergan's Refresh tears, Alcon's Systane Ultra, Johnson and Johnson's Visine, AMO's blink tears
Active Comparator: Systane Ultra
Alcon's Systane Ultra artificial tear
 Drug: Artificial tears
Instill one drop of artificial tears
Other Name: Allergan's Refresh tears, Alcon's Systane Ultra, Johnson and Johnson's Visine, AMO's blink tears
Active Comparator: Visine
Visine artificial tear
 Drug: Artificial tears
Instill one drop of artificial tears
Other Name: Allergan's Refresh tears, Alcon's Systane Ultra, Johnson and Johnson's Visine, AMO's blink tears
Active Comparator: Blink tears
AMO's blink tears artificial tear
 Drug: Artificial tears
Instill one drop of artificial tears
Other Name: Allergan's Refresh tears, Alcon's Systane Ultra, Johnson and Johnson's Visine, AMO's blink tears

Detailed Description:

Tear osmolarity measures the amount of solutes in the human tear film. The higher the reading, the more likely the patient has dry eyes. Some say it has "potential to be the gold standard" of dry eye testing. The investigators study the tear osmolarity at different time points after instillation of artificial tears.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Between the ages of 18 and over inclusive. Males or females Any race or ethnic background Patient is in generally good & stable overall health. Patient likely to comply with study guidelines & study visits. Informed consent signed. Subjective evaluation of symptom of dryness (SESoD): Score 2 (Mild)

-

Exclusion Criteria:

Corneal refractive surgery within 6 months of this study. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Pregnant or lactating women. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

Corneal staining Grade 3 or higher No Restasis for past 3 months Discontinue topical medications for at least 1 week

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227226

Locations
United States, California
Milton M. Hom, OD, FAAO.
Azusa, California, United States, 91702
Sponsors and Collaborators
Hom, Milton M., OD, FAAO
Allergan
Investigators
Principal Investigator: Milton M Hom, OD FAAO Private Practice
  More Information

No publications provided

Responsible Party: Milton M. Hom, OD, FAAO., Private Practice
ClinicalTrials.gov Identifier: NCT01227226     History of Changes
Other Study ID Numbers: 06
Study First Received: October 21, 2010
Last Updated: February 4, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Hom, Milton M., OD, FAAO:
Dry eye

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Tetrahydrozoline
Carboxymethylcellulose Sodium
Nasal Decongestants
 Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Laxatives
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 16, 2013