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A Study Designed to Evaluate Tear Production

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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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 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

Trial contacts and locations

1

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Central trial contact

Alcon Call Center

Data sourced from clinicaltrials.gov

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