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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: ADX-102 Ophthalmic Solution (0.5%); Drug: ADX-102 Ophthalmic Solution (0.1%); Drug: ADX-102 Ophthalmic Lipid Solution (0.5%)

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 lifitigrast 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ADX-102 Ophthalmic Solution (0.5%)	Drug: ADX-102 Ophthalmic Solution (0.5%); ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.
EXPERIMENTAL: ADX-102 Ophthalmic Solution (0.1%)	Drug: ADX-102 Ophthalmic Solution (0.1%); ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.
EXPERIMENTAL: ADX-102 Ophthalmic Lipid Solution (0.5%)	Drug: ADX-102 Ophthalmic Lipid Solution (0.5%); ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess safety and tolerability of ADX-102 formulations using adverse event query.	Evaluate the safety and tolerability of ADX-102 formulations in subjects with dry eye syndrome.	Safety Assessment Period (Day 1 through Day 29)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of ADX-102 on ocular discomfort using the Ora Calibra® Ocular Discomfort scale.	Evaluate the symptoms of ADX-102 on ocular discomfort in subjects with dry eye syndrome.	Efficacy assessment period (Day 1 through Day 29)
Efficacy of ADX-102 on dry eye syndrome symptoms using the Symptom Assessment in Dry Eye (SANDE) scale.	Evaluate the dry eye symptoms of ADX-102 in subjects with dry eye syndrome.	Efficacy assessment period (Day 1 through Day 29)
Efficacy of ADX-102 on dry eye syndrome using the Ocular Surface and Disease Index (OSDI) © questionnaire.	Evaluate the symptoms of ADX-102 in subjects with dry eye syndrome.	Efficacy assessment period (Day 1 through Day 29)
Efficacy of ADX-102 on tear film break-up time (TFBUT©).	Evaluate tear film break-up time of ADX-102 in subjects with dry eye syndrome.	Efficacy assessment period (Day 1 through Day 29)
Efficacy of ADX-102 on fluorescein staining using the Ora Calibra® scale.	Evaluate fluorescein staining of ADX-102 in subjects with dry eye syndrome.	Efficacy assessment period (Day 1 through Day 29)

Collaborators and Investigators

• Sponsor: Aldeyra Therapeutics, Inc.

Publications and helpful links

General Publications

• Clark D, Sheppard J, Brady TC. A Randomized Double-Masked Phase 2a Trial to Evaluate Activity and Safety of Topical Ocular Reproxalap, a Novel RASP Inhibitor, in Dry Eye Disease. J Ocul Pharmacol Ther. 2021 May;37(4):193-199. doi: 10.1089/jop.2020.0087. Epub 2021 Jan 15.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2017
• Primary Completion (ACTUAL): July 6, 2017
• Study Completion (ACTUAL): July 6, 2017

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (ACTUAL): May 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2018
• Last Update Submitted That Met QC Criteria: June 29, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Aldeyra
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: ADX-102-DES-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No