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Evaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01066988
First Posted: February 11, 2010
Last Update Posted: November 18, 2016
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.
Information provided by (Responsible Party):
Alcon Research
  Purpose
The purpose of this study is to evaluate the effects of an investigational lubricant eye drop on tear film lipid layer thickness of dry eye patients.

Condition Intervention
Dry Eye Other: ORB Ocular Emulsion Other: SootheXP Emollient (Lubricant) Eye Drops

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Lipid layer thickness [ Time Frame: Baseline through 120 minutes post instillation ]

Enrollment: 40
Study Start Date: January 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Right Eye
ORB Ocular Emulsion or SootheXP
Other: ORB Ocular Emulsion
lubricant eye drop
Left Eye
ORB Ocular Emulsion or SootheXP
Other: SootheXP Emollient (Lubricant) Eye Drops
lubricant eye drop

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients (minimum age 18) meeting specific criteria for dry eye.

Exclusion Criteria:

  • Use of topical ocular drops within 12 hours of the study visit; or use of topical ocular ointment within 36 hours of the study visit. In addition, cannot use any topical ocular drugs during study period.
  • History or evidence of ocular or systemic medical conditions and/or medications that would confound the evaluation.
  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): NCT01066988


Locations
United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

Publications:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01066988     History of Changes
Other Study ID Numbers: C-09-046
First Submitted: February 9, 2010
First Posted: February 11, 2010
Last Update Posted: November 18, 2016
Last Verified: February 2012

Keywords provided by Alcon Research:
lipid layer thickness

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