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

Aldeyra Therapeutics

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03162783

ADX-102-DES-007

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

51 participants in 3 patient groups

ADX-102 Ophthalmic Solution (0.5%)

Experimental group

Treatment:

Drug: ADX-102 Ophthalmic Solution (0.5%)

ADX-102 Ophthalmic Solution (0.1%)

Experimental group

Treatment:

Drug: ADX-102 Ophthalmic Solution (0.1%)

ADX-102 Ophthalmic Lipid Solution (0.5%)

Experimental group

Treatment:

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