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OpenTrials
Completed

NCT Number: NCT03162783

A Randomized, Double Masked, Clinical Study of 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

ADX-102 Ophthalmic Solution (0.5%)

Drug

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

ADX-102 Ophthalmic Solution (0.1%)

Drug

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

ADX-102 Ophthalmic Lipid Solution (0.5%)

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Aldeyra Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 22, 2017
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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