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Evaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness

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ClinicalTrials.gov Identifier: NCT01066988
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment
Dry Eye Other: ORB Ocular Emulsion Other: SootheXP Emollient (Lubricant) Eye Drops

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2010
Primary Completion Date : February 2010

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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

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

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

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.

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

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

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

Keywords provided by Alcon Research:
lipid layer thickness

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