An interventional study of Systane Balance and Optive Lubricant Eye Drops in Meibomian Gland Dysfunction, sponsored by Southern California College of Optometry at Marshall B. Ketchum University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Southern California College of Optometry at Marshall B. Ketchum University · Not applicable, Interventional, and Treatment
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.
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
172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.
This study's enrollment of 69 is above the median of 50 across 138 interventional studies indexed under Meibomian Gland Dysfunction.
Browse Meibomian Gland Dysfunction studies →Southern California College of Optometry at Marshall B. Ketchum University is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-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. -
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Artificial tear emulsion
Drug: Systane Balance
Artificial tear
Drug: Optive Lubricant Eye Drops
Artificial tear emulsion drop
Artificial tear eye drop
Also known as: Refresh Optive
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
| Milestone | Systane Balance | Optive Lubricant Eye Drops |
|---|---|---|
| Started | 35 | 34 |
| Completed | 33 | 27 |
| Not completed | 2 | 7 |
time in seconds to observer a dark spot in the tear film
| seconds | Systane Balance | Optive Lubricant Eye Drops |
|---|---|---|
| Tear Film Breakup Time | 4.65 ± 1.73 | 4.42 ± 1.14 |
Collected over 6 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Systane Balance | — | 0/35 (0%) | 0/35 (0%) |
| Optive Lubricant Eye Drops | — | 0/34 (0%) | 0/34 (0%) |
| Age, Categorical(Participants) | Systane Balance | Optive Lubricant Eye Drops | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 35 | 34 | 69 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Systane Balance | Optive Lubricant Eye Drops | Total |
|---|---|---|---|
| Mean | 50.7 ± 17.7 | 54.7 ± 17.5 | 52.7 ± 2.8 |
| Sex: Female, Male(Participants) | Systane Balance | Optive Lubricant Eye Drops | Total |
|---|---|---|---|
| Female | 30 | 24 | 54 |
| Male | 5 | 10 | 15 |
| Region of Enrollment(participants) | Systane Balance | Optive Lubricant Eye Drops | Total |
|---|---|---|---|
| United States | 35 | 34 | 69 |
The record gives a start of Sep 2010, a primary completion of Jul 2011 and a completion of Jul 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2021, 9 years 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Southern California College of Optometry at Marshall B. Ketchum University