Study of Efficacy and Tolerability of SYSTANE Complete in Patients With Dry Eye Disease

Alcon

Status: Completed

Conditions: Dry Eye Disease

Treatments: Other: Propylene glycol-based eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT03492541

CDMGD0012401

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical effectiveness and tolerability of SYSTANE® Complete in adult patients with dry eye disease. Fluorescein-stained tear film break-up time (TFBUT) will be evaluated as the primary objective.

Full description

Patients will attend 4 scheduled visits: Screening Visit (Day -7 to Day 0), Visit 1/Baseline Visit (Day 1), Visit 2 (Day 14) and Visit 3 (Day 28).

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have TFBUT of ≤ 5 seconds in at least one eye at Screening visit.
• Must have best corrected visual acuity (BCVA) of ≥ 20/80 (or ≥ 55 letters score or ≥ 0.6 early treatment diabetic retinopathy study (ETDRS) log of the minimum angle of resolution (LogMAR) value) in both eyes at the Screening visit.
• Must be willing to discontinue use of all artificial tear supplements and use only the study product as directed for the entire study duration.

Exclusion criteria

• History of hypersensitivity to the study drug or any of its excipients or to drugs of similar chemical classes.
• Use of any topical ocular medication preserved with benzalkonium chloride or other products known to be toxic to the tear film lipid layer within 1 month prior to the Screening visit.

Other protocol-specified inclusion and 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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134 participants in 1 patient group

SYSTANE Complete

Experimental group

Description:

Propylene glycol-based eye drops, 1 drop in each eye twice a day (BID) (morning and evening) for 28 days. Patients can administer additional doses in between the scheduled daily doses as needed

Treatment:

Other: Propylene glycol-based eye drops