We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tear Osmolarity Over Time With Artificial Tears

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01227226
Recruitment Status : Unknown
Verified February 2011 by Hom, Milton M., OD, FAAO.
Recruitment status was:  Enrolling by invitation
First Posted : October 25, 2010
Last Update Posted : February 7, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The effect of artificial tears on tear osmolarity

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Artificial tears Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Study Start Date : October 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Tears
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Tear osmolarity [ Time Frame: 2 days ]
    Tear osmolarity measured with TearLab instrument


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Milton M. Hom, OD, FAAO., Private Practice
ClinicalTrials.gov Identifier: NCT01227226     History of Changes
Other Study ID Numbers: 06
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: February 7, 2011
Last Verified: February 2011

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

Additional relevant MeSH terms:
Lubricant Eye Drops
Tetrahydrozoline
Ophthalmic Solutions
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents