Phase 2
N=51
A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT03162783 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale. — -0.81; -0.75; -0.82 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ADX-102 Ophthalmic Solution (0.5%) (Drug); ADX-102 Ophthalmic Solution (0.1%) (Drug); ADX-102 Ophthalmic Lipid Solution (0.5%) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aldeyra Therapeutics, Inc.
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale. |
-0.81; -0.75; -0.82 | — |
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.
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;
Data sourced from ClinicalTrials.gov (NCT03162783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.