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The trial is taking place at:
V

Vision Health Institute | Orlando, FL

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Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease

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Alcon

Status

Enrolling

Conditions

Dry Eye Disease

Treatments

Other: FID123300 ocular lubricant

Study type

Interventional

Funder types

Industry

Identifiers

NCT06444516
DEP918-C001

Details and patient eligibility

About

The purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease (DED).

Full description

The study will consist of a Screening visit, a Baseline visit on Day 1, a remote Compliance Check on Day 14, and an Exit visit on Day 30. The expected study duration of participation for each subject is 37 days, with 30 ± 5 days of exposure to the investigational product.

Enrollment

185 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Willing and able to understand and sign an approved informed consent form.
  • Exhibit symptoms of dry eye at the Screening visit.
  • Best Corrected Visual Acuity equal to or better than 20/80 Snellen in each eye at the Screening visit.
  • Willing to discontinue use of all artificial tear supplements and use only the study product as directed starting at Visit 2/Day 1.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Pregnant, breastfeeding, or planning to become pregnant during the study.
  • Ocular abnormalities that could adversely affect the safety or efficacy outcome.
  • Uncontrolled active systemic diseases.
  • Use of systemic medications known to cause dry eye.
  • Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

185 participants in 1 patient group

FID123300
Experimental group
Description:
One drop of FID123300 ocular lubricant in each eye on Day 1 in the morning, followed by at least one drop in each eye 4 times a day on Days 2-30.
Treatment:
Other: FID123300 ocular lubricant

Trial contacts and locations

9

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Central trial contact

Alcon Call Center

Data sourced from clinicaltrials.gov

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