ClinicalTrials.Veeva

Menu

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

Alcon logo

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)

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

Trial contacts and locations

5

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems