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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
History of Changes

September 21, 2010
May 31, 2013
September 2010
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01207752 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction
Evaluation of the Efficacy of an Ocular Emulsion on the Signs and Symptoms of Meibomian Gland Dysfunction

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Meibomian Gland Dysfunction
  • Drug: Systane Balance
    Artificial tear emulsion drop
  • Drug: Optive Lubricant Eye Drops
    Artificial tear eye drop
  • Experimental: Systane Balance
    Artificial tear emulsion
    Intervention: Drug: Systane Balance
  • Active Comparator: Optive Lubricant Eye Drops
    Artificial tear
    Intervention: Drug: Optive Lubricant Eye Drops
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
July 2011
July 2011   (final data collection date for primary outcome measure)

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. -
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01207752
SCCO 10-6
No
Jerry R. Paugh, OD, PhD, Southern California College of Optometry
Southern California College of Optometry
Alcon Research
Principal Investigator: Jerry R Paugh, OD, PhD Southern California College of Optometry
Southern California College of Optometry
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP