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Evaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01066988
First received: February 9, 2010
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  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 Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Lipid layer thickness [ Time Frame: Baseline through 120 minutes post instillation ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066988

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01066988     History of Changes
Other Study ID Numbers: C-09-046
Study First Received: February 9, 2010
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
lipid layer thickness

Additional relevant MeSH terms:
Tetrahydrozoline
Emollients
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on June 17, 2013