Meibomian Gland Dysfunction
Conditions
Keywords
dry eye, MGD, tear film break up time
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
Interventions
DRUGSystane Balance
Artificial tear emulsion drop
Artificial tear eye drop
Sponsors
Alcon Research
Southern California College of Optometry at Marshall B. Ketchum University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Film Breakup Time | Measured 2 hours after in-office administration of a single drop of test solution | time in seconds to observer a dark spot in the tear film |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Systane Balance Artificial tear emulsion
Systane Balance: Artificial tear emulsion drop | 35 |
| Optive Lubricant Eye Drops Artificial tear
Optive Lubricant Eye Drops: Artificial tear eye drop | 34 |
| Total | 69 |
Baseline characteristics
| Characteristic | Optive Lubricant Eye Drops | Systane Balance | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 35 Participants | 69 Participants |
| Age, Continuous | 54.7 years STANDARD_DEVIATION 17.5 | 50.7 years STANDARD_DEVIATION 17.7 | 52.7 years STANDARD_DEVIATION 2.8 |
| Region of Enrollment United States | 34 participants | 35 participants | 69 participants |
| Sex: Female, Male Female | 24 Participants | 30 Participants | 54 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 34 |
| serious Total, serious adverse events | 0 / 35 | 0 / 34 |
Outcome results
Primary
Tear Film Breakup Time
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Systane Balance | Tear Film Breakup Time | 4.65 seconds | Standard Deviation 1.73 |
| Optive Lubricant Eye Drops | Tear Film Breakup Time | 4.42 seconds | Standard Deviation 1.14 |
p-value: 0.55t-test, 2 sided