Intervention: PROPYLENE GLYCOL
Trial phase: Not Applicable
SMILES: CC(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 110
Group description: All subjects exposed to Systane® Balance
Eligibility criteria:
Inclusion Criteria:

Must have all of the following in at least 1 eye at Screening:

Meibomian Gland Dysfunction (MGD) grading for Expressibility ≤ 2 and Meibum Quality ≤ 2,
The average of 3 measures of TFBUT ≤ 5 seconds, and
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.