A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome

Phase 2

Completed

Interventions: Drug: ADX-102 Ophthalmic Solution (0.5%)
Drug: ADX-102 Ophthalmic Solution (0.1%)
Drug: ADX-102 Ophthalmic Lipid Solution (0.5%)

Brief Summary: The objective of this study is to evaluate the safety, tolerability, and pharmacodynamic activity of ADX-102 Ophthalmic Solutions and ADX-102 Ophthalmic Lipid Solution in subjects with dry eye syndrome.

Recruitment & Eligibility

Inclusion Criteria

Be at least 18 years of age of either gender and any race;
Have a reported history of dry eye for at least 6 months prior to Visit 1;
Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;

Exclusion Criteria

Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
Have used cyclosporine 0.05% or lifitegrast 5.0% ophthalmic solution within 45 days of Visit 1;
Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within the last 6 months;
Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;

Arm && Interventions

Group	Intervention	Description
ADX-102 Ophthalmic Solution (0.5%)	ADX-102 Ophthalmic Solution (0.5%)	-
ADX-102 Ophthalmic Solution (0.1%)	ADX-102 Ophthalmic Solution (0.1%)	-
ADX-102 Ophthalmic Lipid Solution (0.5%)	ADX-102 Ophthalmic Lipid Solution (0.5%)	-

Primary Outcome Measures

Name	Time	Method
Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.	Efficacy assessment period (Day 1 through Day 29), Day 29 reported.	Change from baseline of ADX-102 on ocular discomfort in subjects with dry eye disease using the Ora Calibra® Ocular Discomfort Scale (0 = least, 4 = most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.

Secondary Outcome Measures