The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction
This study has been completed.
Sponsor:
Southern California College of Optometry
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
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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
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 June 18, 2013