A Study Designed to Evaluate Tear Production

Alcon

Status and phase

Begins enrollment this month

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 study.

Enrollment

80 estimated 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.