Systane Complete Multi-symptom Relief

Alcon

Status: Completed

Conditions: Dry Eye Disease

Treatments: Other: Systane Complete

Study type: Interventional

Funder types: Industry

Identifiers

NCT05056155

DEC262-P002

Details and patient eligibility

About

The purpose of this study is to demonstrate effective symptom relief with the use of Systane Complete among subjects with dry eye disease (DED).

Full description

Subjects will be expected to attend a screening/baseline visit and one additional visit at Day 28 (± 2 days), with a telephone call visit conducted at Day 14 (± 2 days). Individual duration of subject participation will be approximately 28 days.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form.
• Willing and able to attend all study visits as required per protocol.
• Have dry eye symptoms as specified in the protocol.
• Willing to discontinue use of all habitual artificial tear supplements for the entire study duration.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Ocular conditions as specified in the protocol.
• Contact lens use within one week prior to screening visit.
• Use of medications as specified in the protocol.
• Pregnant or breast feeding.
• Other protocol-defined 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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119 participants in 1 patient group

Systane Complete

Experimental group

Description:

First dose of Systane Complete in both eyes on Day 0, followed by Systane Complete self-administered 4 times daily for 28 days

Treatment:

Other: Systane Complete