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

A 15-day Run-in phase will precede a 90-day Treatment period. The Treatment period will be
conducted in 2 phases. In Phase 1, participants will be randomized to either Systane®
Balance or Saline and dose 4 times a day for 35 days. In Phase II (Day 35-90) participants
will continue 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
meet 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.