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The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction

Primary Purpose

Meibomian Gland Dysfunction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Systane Balance

Optive Lubricant Eye Drops

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring dry eye, meibomian gland dysfunction, tear film break up time

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

Eye Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Systane Balance

Optive Lubricant Eye Drops

Arm Description

Artificial tear emulsion

Artificial tear

Outcomes

Primary Outcome Measures

Tear Film Breakup Time

time in seconds to observer a dark spot in the tear film

Secondary Outcome Measures

Full Information

NCT ID

NCT01207752

First Posted

September 21, 2010

Last Updated

March 16, 2021

Sponsor

Southern California College of Optometry at Marshall B. Ketchum University

Collaborators

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01207752

Brief Title

The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction

Official Title

Evaluation of the Efficacy of an Ocular Emulsion on the Signs and Symptoms of Meibomian Gland Dysfunction

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Southern California College of Optometry at Marshall B. Ketchum University

Collaborators

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meibomian Gland Dysfunction

Keywords

dry eye, meibomian gland dysfunction, tear film break up time

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Systane Balance

Arm Type

Experimental

Arm Description

Artificial tear emulsion

Arm Title

Optive Lubricant Eye Drops

Arm Type

Active Comparator

Arm Description

Artificial tear

Intervention Type

Drug

Intervention Name(s)

Systane Balance

Intervention Description

Artificial tear emulsion drop

Intervention Type

Drug

Intervention Name(s)

Optive Lubricant Eye Drops

Intervention Description

Artificial tear eye drop

Primary Outcome Measure Information:

Title

Tear Film Breakup Time

Description

time in seconds to observer a dark spot in the tear film

Time Frame

Measured 2 hours after in-office administration of a single drop of test solution

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jerry R Paugh, OD, PhD

Organizational Affiliation

Southern California College of Optometry at Marshall B. Ketchum University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eye Care Center

City

Fullerton

State/Province

California

ZIP/Postal Code

92831

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction

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