clinical outcomes following treatment with systane® balance in dry eye subjects

Conditions: Dry Eye

Summary: the purpose of this study is to demonstrate the superior efficacy of systane® balance over preservative-free 0.9% saline following 35 days of qid (4 times a day) dosing in treating dry eye subjects with lipid deficiency.

this study consisted of 4 visits conducted during 3 sequential phases: the run-in phase (which included a screening visit and run-in period), treatment phase i and treatment phase ii. in phase i, subjects were randomized to either systane® balance or saline and dosed 4 times a day for 35 days. in phase ii (day 35-90) subjects continued to dose with their assigned product on an as-needed basis.

Eligibility criteria:
inclusion criteria: * must have all of the following in at least 1 eye at screening: 1. meibomian gland dysfunction (mgd) grading for expressibility ≤ 2 and meibum quality ≤ 2, 2. the average of 3 measures of tfbut ≤ 5 seconds, and 3. unanesthetized schirmer i test of ≥ 3 mm. * must have an ocular surface disease index (osdi) score ≥ 18 at visit 1 prior to randomization (ie, after 2 weeks of run-in with preservative-free 0.9% saline administered 4 times a day). * must have best-corrected visual acuity of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (etdrs) chart (letter read method). * physician diagnosis of dry eye at least 6 months prior to screening visit. * willing and able to attend all study visits. * must sign a written informed consent form. * other protocol-defined inclusion criteria may apply. exclusion criteria: * subjects on topical ocular treatments containing benzalkonium chloride (bak), or other products with known toxicity to the corneal surface, within 30 days of screening. * subjects who have started, stopped, or changed a lid hygiene regimen within 30 days of screening. * use of any artificial tears/lubricants/gels/rewetting drops within 4 hours of screening. * women of childbearing potential are excluded from participating in this study if they met any of the following conditions: * currently pregnant, or * test positive for pregnancy at screening visit, or * currently breast feeding, or * are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. * hypersensitivity to the use of any of the study products or allergy to any ingredient in the study products. * has an active ocular allergy. * any ocular abnormalities that could adversely affect the safety or efficacy outcome, including eyelid anomalies, corneal disorders, history of herpes simplex, etc. * subjects taking any systemic medication known to cause dry eye unless they have been on stable therapy/dosage for at least 30 days prior to screening and will remain on a stable dosage for the duration of the study. * history of any ocular or intraocular surgery (including periocular botox injections), eyelid surgery, keratorefractive procedure, corneal transplant and its variants, or serious ocular trauma within 1 year of screening. * active ocular infection (bacterial, viral or fungal), active inflammation not associated with dry eye such as uveitis, iritis, active blepharitis, active allergic conjunctivitis, etc. * subjects with punctal plug insertion or diathermy procedure initiated within 30 days of screening. * any significant illnesses that could be expected to interfere with the study parameters. * subjects with active oculodermal rosacea with meibomian gland dysfunction. * participation in an investigational drug or device trial within 30 days of screening. * contact lens use within 30 days prior to screening, or unwilling to avoid contact lens use during the course of the study. * unwilling to avoid the use of additional artificial tears/lubricants/gels/rewetting drops (other than the assigned study medication) throughout the course of the study. * other protocol-defined exclusion criteria may apply.

Keywords: dry eye lipid deficiency tear film break-up time