A Single-Center, Phase 2a, Randomized, Double Masked, Clinical Study to Assess the Safety, Tolerability, and Pharmacodynamic Activity of ADX-102 Ophthalmic Solution in Subjects With Dry Eye Syndrome

Aldeyra Therapeutics, Inc.1 site in 1 country51 target enrollmentMay 15, 2017

InterventionsADX-102 Ophthalmic Solution (0.5%)ADX-102 Ophthalmic Solution (0.1%)ADX-102 Ophthalmic Lipid Solution (0.5%)

DrugsADX-102 Ophthalmic Solution (0.5%)ADX-102 Ophthalmic Solution (0.1%)ADX-102 Ophthalmic Lipid Solution (0.5%)

Overview

Phase: Phase 2
Intervention: ADX-102 Ophthalmic Solution (0.5%)
Conditions: Dry Eye Syndromes
Sponsor: Aldeyra Therapeutics, Inc.
Enrollment: 51
Locations: 1
Primary Endpoint: Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 15, 2017

End Date

July 6, 2017

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Aldeyra Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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;

Arms & Interventions

ADX-102 Ophthalmic Solution (0.5%)

Intervention: ADX-102 Ophthalmic Solution (0.5%)

ADX-102 Ophthalmic Solution (0.1%)

Intervention: ADX-102 Ophthalmic Solution (0.1%)

ADX-102 Ophthalmic Lipid Solution (0.5%)

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

Outcomes

Primary Outcomes

Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.

Time Frame: 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.