Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease

• Pilocarpine Ophthalmic Topical Cream, Dose 1 (Drug), also known as GLK-301: Pilocarpine Ophthalmic Topical Cream, Dose 1
• Pilocarpine Ophthalmic Topical Cream, Dose 2 (Drug), also known as GLK-301: Pilocarpine Ophthalmic Topical Cream, Dose 2
• Pilocarpine Ophthalmic Topical Cream, Dose 3 (Drug), also known as GLK-301: Pilocarpine Ophthalmic Topical Cream, Dose 3
• Placebo Ophthalmic Topical Cream (Drug), also known as Placebo: Placebo Ophthalmic Topical Cream

Primary outcomes

• Mean change from baseline in the VAS score at Day 28 visit. [Baseline and Day 28]: Mean change from baseline in the VAS score at Day 28 visit. Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)
• Mean change from baseline in Fluorescein Staining at the Day 28 visit. [Baseline and Day 28]: Mean change from baseline in Fluorescein Staining at the Day 28 visit.

Secondary outcomes

• Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits [Baseline and Days 4, 8, and 14]: Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Male or female, 18 years of age or older at the Screening Visit
* Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form
* Diagnosis of dry eye

Exclusion Criteria:

* Sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation
* History of eczema, dermatitis or skin sensitivity to over-the-counter personal care products such as lotions, creams, makeup, soaps, etc.
* History of, or active iritis or uveitis in either eye
* Pre-existing retinal disease in either eye that may predispose subjects to retinal detachment