Clinical trial NCT06544694: A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease
Official title: A Phase 3b Study to Investigate the Effect of 0.003% AR-15512 on the Ocular Surface Characteristics of Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Keywords: Dry Eyes
Eye Drops
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: Qualified subjects will enter a 14-day run-in period, followed by a 13-week randomized treatment period, for a total individual duration of participation of approximately 15 weeks. During the run-in period, subjects will administer Artificial Tears (REFRESH® Classic) as one drop in each eye twice daily.

This is a Phase 3b study.

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.

Primary outcomes:
measure: Percentage change from baseline in goblet cell density at Day 90
timeFrame: Baseline (Day 1 pre-instillation), Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Garner
country: United States
facility: Oculus Research
state: North Carolina
city: Leland
country: United States
facility: Wilmington Eye
state: North Carolina
city: Shelby
country: United States
facility: CORE, Inc.
state: North Carolina
city: Houston
country: United States
facility: Butchertown Clinical Trials
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Pharma
role: STUDY_DIRECTOR
References: