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Phase 3 N=80 Randomized Double-blind Treatment

A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease

Dry Eye Disease

Enrolled (actual)
80
Serious AEs
0.6%
Results posted
Mar 2026
Primary outcome: Primary: Least Squares Mean Percentage Change From Baseline in Goblet Cell Density at Day 90 for 0.003% AR-15512 — 94.61 percent change — p=0.1765

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
0.003% AR-15512 ophthalmic solution (Drug); Artificial Tears (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Alcon Research
Primary completion
Mar 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Least Squares Mean Percentage Change From Baseline in Goblet Cell Density at Day 90 for 0.003% AR-15512
94.61 0.1765

Summary

The purpose of this study is to evaluate the effect of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) on ocular surface characteristics of subjects with dry eye disease (DED).

Eligibility Criteria

Key Inclusion Criteria

  • Have a previous history of DED, clinician diagnosed or patient reported, within the previous 6 months prior to the Screening visit.
  • Have used artificial tears for DED symptoms within 2 months prior to the Screening visit.
  • Corrected visual acuity equal to or better than logarithm Minimum angle of reflection (logMar) +0.7 (Snellen equivalent equal to or better than 20/100), as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at both the Screening and Baseline visits.
  • Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history.
  • Other protocol specified inclusion criteria may apply.

Key Exclusion Criteria

  • History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety.
  • Current evidence of other significant ophthalmic disease requiring topical medication (e.g., glaucoma, ocular hypertension), or other ophthalmic disease which the investigator believes may interfere with study findings or interpretation.
  • History of ocular surgery within 1 year prior to the Screening visit; history of corneal transplant in one or both eyes.
  • Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study.
  • Regular use, as assessed by the investigator, of lid hygiene or heat masks within 14 days prior to the Screening visit or any planned use during the study.
  • Use of lid heating therapy or Meibomian gland probing/therapeutic expression within 1 year prior to the Screening visit or anticipated during the study.
  • Other protocol-specified exclusion criteria may apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06544694). 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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