The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Jerry R. Paugh, OD, PhD, Southern California College of Optometry
ClinicalTrials.gov Identifier:
NCT01207752
First received: September 21, 2010
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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 Intervention
Meibomian Gland Dysfunction
Drug: Systane Balance
Drug: Optive Lubricant Eye Drops

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Southern California College of Optometry:

Primary Outcome Measures:
  • Tear film breakup time [ Time Frame: Measured 2 hours after in-office administration of a single drop of test solution ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: September 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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. -

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: September 21, 2010
Last Updated: May 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Southern California College of Optometry:
dry eye, meibomian gland dysfunction, tear film break up time

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

ClinicalTrials.gov processed this record on July 26, 2014