The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction

NCT ID: NCT01207752

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-07-31

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.

Detailed Description

This investigation will involve approximately 90 MGD subjects, randomly assigned to either the Systane Balance treatment group or a control group using Optive™ Lubricant Eyedrops (Allergan), a low-viscosity artificial tear. Both arms will dose the drops four times per day and the treatment trial will be conducted for 6 months. The age range will be 18 years and older, with no upper age limit. Standard diagnostic tests for dry eye, as recommended by the NEI-Industry Workshop report,8 but with updated criteria in some instances, will be used to define clinical dry eye of the MGD sub-type. The three major tests will be: symptoms using a validated questionnaire (Schein), evidence of ocular surface damage, and demonstration of tear instability. The subjects will be enrolled if they consent and are confirmed as MGD subjects using the established clinical criteria used at SCCO of gland dropout Grade 1 per lower eyelid using meiboscopy,6, 9 or secretion quality Grade 1 in any of the three sectors (temporal, central, nasal) upon gland expression9, 10 using the recently developed Korb device.11 The principal outcome measure will be the tear film breakup time (TBUT), in seconds, at two hours post drop instillation. The two-hour TBUT value will be used to compare the control and test formulation at baseline and visits 3, 5 and 7. TBUT will be measured using 2.0 l of 1.0% NaFl. Exploratory outcome measures will include TBUT (seconds; change over time), corneal staining (change over time; 0 - 20 scale), symptoms (Schein and MGD-specific preliminary questionnaire score), drop comfort, Surface Regularity Index (a measure of surface disruption), lipid layer grade (1 - 5 Yokoi scale), meibum excreta quality, gland drop out and lid margin appearance all monitored as the change over time from baseline. Treatment comparisons will be made at each timepoint

Conditions

Meibomian Gland Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Systane Balance

Artificial tear emulsion

Group Type: EXPERIMENTAL

Systane Balance

Intervention Type: DRUG

Artificial tear emulsion drop

Optive Lubricant Eye Drops

Artificial tear

Group Type: ACTIVE_COMPARATOR

Optive Lubricant Eye Drops

Intervention Type: DRUG

Artificial tear eye drop

Interventions

Systane Balance

Artificial tear emulsion drop

Intervention Type: DRUG

Optive Lubricant Eye Drops

Artificial tear eye drop

Intervention Type: DRUG

Other Intervention Names

Refresh Optive

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Southern California College of Optometry at Marshall B. Ketchum University

OTHER

Sponsor Role: lead

Responsible Party

Jerry Paugh

Professor Emeritus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerry R Paugh, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

Southern California College of Optometry at Marshall B. Ketchum University

Locations

Eye Care Center

Fullerton, California, United States

Countries

United States

Other Identifiers

SCCO 10-6

Identifier Type: -

Identifier Source: org_study_id