Clinical trial NCT06544707: A Study Designed to Evaluate Tear Production
Official title: A Phase 3b Open-Label Study Designed to Evaluate Tear Production Stimulated by 0.003% AR-15512
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: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate tear production following acute administration of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) in subjects with dry eye disease (DED).

Detailed description: Qualified subjects will attend a single visit.

This is a Phase 3b. 2 stage study. In Phase 1, approximately 40 subjects will be enrolled, after which the study will be paused and an analysis will be conducted. Results from the Stage 1 analysis will help inform the design of Stage 2. An additional 40 subjects are planned for Stage 2.

For both stages, the primary endpoint and analysis will remain the same. Stage 2 will be tested independently with no pooling of data between stages.

Eligibility criteria: Key Inclusion Criteria:

* Within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported.
* Within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms.
* Have a corrected visual acuity score of 20/200 or better in both eyes.
* Have 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:

* Current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration).
* History of ocular surgery within 1 year of the Study Visit.
* Use of contact lenses in either eye within 7 days of the Study Visit.
* Use of lid hygiene (all forms of lid care) or heat masks within 7 days of the Study Visit.
* Use of any topical ocular anti-inflammatory medications, any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 30 days of the Study Visit.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline (pre-drop compared to 3 minutes post-drop) in tear meniscus height (TMH) as measured by optical coherence tomography (OCT) - Stage 1
timeFrame: Day 1, Minute 0 (pre-instillation); Day 1, Minute 3 (post-instillation) - Stage 1
measure: Change from baseline (pre-drop compared to 3 minutes post-drop) in tear meniscus height (TMH) as measured by optical coherence tomography (OCT) - Stage 2
timeFrame: Day 1, Minute 0 (pre-instillation); Day 1, Minute 3 (post-instillation) - Stage 2
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Pharma
role: STUDY_DIRECTOR
References: