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Phase 2 N=300 Randomized Quadruple-blind Treatment

A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

Dry Eye Syndrome

Enrolled (actual)
300
Serious AEs
0.7%
Results posted
Feb 2025
Primary outcome: Primary: Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness. — -0.7; -0.5; -0.4 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Reproxalap Ophthalmic Solution (0.25%) (Drug); Reproxalap Ophthalmic Solution (0.1%) (Drug); Vehicle Ophthalmic Solution (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Aldeyra Therapeutics, Inc.
Primary completion
Jul 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness.
-0.7; -0.5; -0.4

Summary

A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease

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 used any eye drops within 2 hours of Visit 1;
  • 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 90 days of Visit 1;
  • Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
  • Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03404115). 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.

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