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

NCT03162783 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ADX-102-DES-007
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes

Keywords

Aldeyra

Outcome Measures

Primary Outcomes (1)

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

  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.

  Efficacy assessment period (Day 1 through Day 29), Day 29 reported.

Study Arms (3)

ADX-102 Ophthalmic Solution (0.5%)

EXPERIMENTAL

Drug: ADX-102 Ophthalmic Solution (0.5%)

ADX-102 Ophthalmic Solution (0.1%)

EXPERIMENTAL

Drug: ADX-102 Ophthalmic Solution (0.1%)

ADX-102 Ophthalmic Lipid Solution (0.5%)

EXPERIMENTAL

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

Interventions

ADX-102 Ophthalmic Solution (0.5%) DRUG

ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.

ADX-102 Ophthalmic Solution (0.5%)

ADX-102 Ophthalmic Solution (0.1%) DRUG

ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.

ADX-102 Ophthalmic Solution (0.1%)

ADX-102 Ophthalmic Lipid Solution (0.5%) DRUG

ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.

ADX-102 Ophthalmic Lipid Solution (0.5%)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Related Publications (1)

• 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.

  PMID: 33450164 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Sr. Director, Clinical Operations
• Organization: Aldeyra Therapeutics, Inc.

bcavanagh@aldeyra.com

781-257-3063

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 22, 2017
• Study Start: May 15, 2017
• Primary Completion: July 6, 2017
• Study Completion: July 6, 2017
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)