NCT01733745.

Trial name or title	SYSTANE family efficacy in meibomian gland functionality for lipid deficient evaporative dry eye subjects
Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): single‐center Number randomized (total and per group): 26 participants in total; 13 participants in each group ("experimental" group and "active comparator" group) Unit of randomization (individual or eye): not reported Exclusions after randomization: none Losses to follow‐up: none Number analyzed (total and per group): 26 participants in total; 13 participants in each group ("experimental" group and "active comparator" group) Unit of analysis (individual or eye): not reported Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N
Participants	Participant characteristics Country: United States Age (mean ± SD, range): 41.7 ± 19.8 years total; 38.1 ± 19.9 years in the experimental group; 45.4 ± 19.8 years in the active comparator group Gender: 5 men and 21 women in total; 2 men and 11 women in the experimental intervention group; 3 men and 10 women in the active comparator group Inclusion criteria: 1. Clinical diagnosis of lipid deficient evaporative dry eye; meibomian gland functionality ‐ not more than 6 glands yielding liquid secretion 2. Willing to discontinue the use of all other meibomian glands 3. Dysfunction management before receiving the study test article at visit 1, up until the end of the study period 4. Best‐corrected visual acuity of 20/40 Snellen or better in each eye 5. Must be able to follow instructions and must be willing to attend required study visits 6. Read, sign, and date an ethics committee reviewed and approved informed consent form 7. Other protocol‐defined inclusion criteria may apply Exclusion criteria: 1. History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months 2. Current punctal occlusion of any type (eg, collagen plugs, silicone plugs) 3. History of intolerance or hypersensitivity to any component of study medications 4. History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye 5. Pregnant or lactating at the time of enrollment 6. Not willing to take adequate precautions to avoid becoming pregnant during the study 7. Use of any concomitant topical ocular medications during the study period 8. Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days before visit 1 9. Ocular conditions that may preclude safe administration of either drop under investigation 10. Unwilling to discontinue contact lens wear during the study period and for at least 1 week before visit 1 11. Participation in an investigational drug or device study within 30 days of entering this study 12. Other protocol‐defined exclusion criteria may apply Equivalence of baseline characteristics? (Y/N): Y
Interventions	Intervention #1 (experimental group): SYSTANE Lid Wipes administered to treated eye(s) once a day; SYSTANE BALANCE Lubricant Eye Drops administered to treated eye(s), 1 drop, 4 times a day; SYSTANE Vitamins, 2 soft gels ingested daily Intervention #2 (active comparator group): microfiber towels as warm compress once daily for 8 minutes Length of follow‐up: 3 months Notes: none
Outcomes	Primary outcome(s): number of meibomian glands yielding liquid secretion Secondary outcome(s): Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire; OSDI Adverse events reported? (Y/N): Y Measurement time points (specify intervals at which outcomes were assessed): not reported Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Starting date	February 2013
Contact information	Donald R. Korb, O.D. Korb and Associates
Notes	Recruitment status: completed First posted: November 2012 Last post updated: June 2018