A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome
Completed · Phase 2
Conditions studied: Dry Eye Syndromes
In brief
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.
Key facts
- Study ID
- NCT03162783
- Run by
- Aldeyra Therapeutics, Inc.
- People needed
- 51
- Starts
- 2017-05-15
- Expected to finish
- 2017-07-06
- Last updated by the study team
- 2025-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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;
Where it is running
- Andover Eye Associates — Andover, Massachusetts, United States
Full record on ClinicalTrials.gov
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