Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects

Evaluation of Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects With Lipid Deficiency

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.

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.