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

Dry Eye Disease Clinical Trial

Official title:

Evaluation of the Clinical Efficacy and Tolerability of SYSTANE Complete in Adult Patients With Dry Eye Disease Following Topical Ocular Use for 4 Weeks: A Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492541
• Other study ID #: CDMGD0012401
• Status: Completed
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: May 14, 2019

Study information

• Verified date: June 2019
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: May 14, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Other:
• Propylene glycol-based eye drops
Nano-emulsion ocular lubricant

Locations

Country	Name	City	State
Spain	Investigative Site	Valladolid	Castilla Y Leon
United Kingdom	Investigative Site	London
United States	Investigative Site	Kansas City	Missouri
United States	Investigative Site	Kansas City	Missouri
United States	Investigative Site	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Countries where clinical trial is conducted

United States,  Spain,  United Kingdom, 

Outcome

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