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

Not Applicable

Completed

• Conditions: Dry Eye Disease
• Interventions: Other: Propylene glycol-based eye drops

• Registration Number: NCT03492541
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-10
• Study Start: 2018-07-18
• Primary Completion: 2019-04-30
• Study Completion: 2019-05-14
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-10
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SYSTANE Complete	Propylene glycol-based eye drops	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

Primary Outcome Measures

Name	Time	Method
Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14	Baseline, Day 14	TFBUT will be assessed using fluorescein, an ocular staining dye

Secondary Outcome Measures

Name	Time	Method
Change from baseline in ocular discomfort at Day 14	Baseline, Day 14	As reported by the patient using a Visual Analogue Scale (VAS)
Change from baseline in EQ-5D-5L score(s) at Day 28	Baseline, Day 28	As reported by the patient using a validated questionnaire
Tolerability assessment score	Day 1	As reported by the patient using an assessment questionnaire post drop instillation
Change from baseline in TFBUT at Day 28	Baseline, Day 28	TFBUT will be assessed using fluorescein, an ocular staining dye
Change from baseline in corneal staining score at Day 28	Baseline, Day 28	Assessment of ocular staining using staining dye under a slit lamp
Change from baseline in dry eye symptom score at Day 1	Baseline, Day 1	As reported by the patient using a Likert scale post drop instillation
Soothing sensation score	Day 1	As reported by the patient using a Likert scale post drop instillation
Change from baseline in response to the revised IDEEL questionnaire at Day 28	Baseline, Day 28	As reported by the patient using a subjective questionnaire

Trial Locations

Locations (1)

Investigative Site; 🇬🇧 London, United Kingdom