ClinicalTrials.gov
ClinicalTrials.gov Menu

The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction

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: NCT01207752
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : June 4, 2013
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Jerry R. Paugh, OD, PhD, Southern California College of Optometry

Brief Summary:
The aim of this study will be to determine the efficacy of this novel, lipid-containing artificial tear on the signs and symptoms of meibomian gland disease.

Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction Drug: Systane Balance Drug: Optive Lubricant Eye Drops Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of an Ocular Emulsion on the Signs and Symptoms of Meibomian Gland Dysfunction
Study Start Date : September 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Systane Balance
Artificial tear emulsion
Drug: Systane Balance
Artificial tear emulsion drop
Active Comparator: Optive Lubricant Eye Drops
Artificial tear
Drug: Optive Lubricant Eye Drops
Artificial tear eye drop



Primary Outcome Measures :
  1. Tear film breakup time [ Time Frame: Measured 2 hours after in-office administration of a single drop of test solution ]


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:   No
Criteria

Inclusion Criteria:

  • Schein symptom score (all 6 questions) of greater than 5,
  • evidence of MGD changes in both eyes (i.e.,
  • lower eyelid secretion quality score greater than 1.0 (0 - 3 scale) OR gland dropout score greater than 1.0 (i.e., greater than 25% of entire lower eyelid) as demonstrated by meiboscopy, and corneal staining of grade 4.0 or greater (0 - 20 scale).

Exclusion Criteria:

  • contact lens wear, use of topical ocular medication other than artificial tears (use of Restasis is specifically excluded),
  • unstable systemic medication use (i.e., anti-histamines, steroids, etc.), recent (within 6 months of study start) ocular trauma or surgery,
  • diabetes, aqueous deficient dry eye (defined as a Schirmer I value (without anesthetic) of < 5 mm of wetting in 5 minutes in either eye), and use of punctal plugs.

-Subjects taking omega 3 fatty acid supplements for dry eye can be included so long as their intake is stable for the prior six months and they meet the inclusion criteria above. -


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): NCT01207752


Locations
United States, California
Eye Care Center
Fullerton, California, United States, 92831
Sponsors and Collaborators
Southern California College of Optometry
Alcon Research
Investigators
Principal Investigator: Jerry R Paugh, OD, PhD Southern California College of Optometry

Responsible Party: Jerry R. Paugh, OD, PhD, Professor, Associate Dean for Research, Southern California College of Optometry
ClinicalTrials.gov Identifier: NCT01207752     History of Changes
Other Study ID Numbers: SCCO 10-6
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: May 2013

Keywords provided by Jerry R. Paugh, OD, PhD, Southern California College of Optometry:
dry eye, meibomian gland dysfunction, tear film break up time

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