Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.

The clinical trial is a Phase 2, multi center, randomized, double masked and placebo controlled study.

During a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Placebo Ophthalmic Solution (vehicle) bilaterally. During the screening period, exposure to the CAE® will be conducted to ascertain eligibility to enter the study at Visit 1 and Visit 2. Those who qualify at Visit 2 will be randomized to receive study drug in a double-masked fashion for 12 weeks. The CAE® exposure will occur at all Visits.

Inclusion Criteria:

• Be at least 18 years of age.
• Provided written informed consent.
• Have a reported history of dry eye
• Have a history of use or desire to use eye drops for dry eye symptoms
• Have corrected visual acuity greater than or equal to +0.7 in both eyes

Exclusion Criteria:

• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal)
• Have any planned ocular and/or lid surgeries over the study period.
• Have an uncontrolled systemic disease.
• Be a woman who is pregnant, nursing or planning a pregnancy.
• Be a woman of childbearing potential who is not using an acceptable means of birth control
• Have a known allergy and/or sensitivity to the test article or its components.
• Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
• Have used an investigational drug or device within 30 days of Visit 1
• Be unable or unwilling to follow instructions, including participation in all study assessments and visits