A Study Designed to Evaluate Tear Production

Alcon

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: 0.003% AR-15512

Study type: Interventional

Funder types: Industry

Identifiers

NCT06544707

DEF512-E002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

0.003% AR-15512

Experimental group

Description:

One drop in each eye in a staggered cadence (left eye followed by dosing of the right eye) approximately 2-4 hours apart

Treatment:

Drug: 0.003% AR-15512