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

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT03492541

Collaborator

(none)

134

Enrollment

Locations

Arm

9.9

Actual Duration (Months)

26.8

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Other: Propylene glycol-based eye drops	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

134 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 18, 2018

Actual Primary Completion Date :

Apr 30, 2019

Actual Study Completion Date :

May 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SYSTANE Complete 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	Other: Propylene glycol-based eye drops Nano-emulsion ocular lubricant Other Names: SYSTANE® Complete

Arm

Intervention/Treatment

Experimental: SYSTANE Complete

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

Other: Propylene glycol-based eye drops

Nano-emulsion ocular lubricant

Other Names:

SYSTANE® Complete

Outcome Measures

Primary Outcome Measures

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

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
Tolerability assessment score [Day 1]
As reported by the patient using an assessment questionnaire post drop instillation
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 corneal staining score at Day 28 [Baseline, Day 28]
Assessment of ocular staining using staining dye under a slit lamp
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
Change from baseline in EQ-5D-5L score(s) at Day 28 [Baseline, Day 28]
As reported by the patient using a validated questionnaire
Change from baseline in TFBUT at Day 28 [Baseline, Day 28]
TFBUT will be assessed using fluorescein, an ocular staining dye

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Site	Kansas City	Missouri	United States	64133
2	Investigative Site	Kansas City	Missouri	United States	64155
3	Investigative Site	Norfolk	Virginia	United States	23502
4	Investigative Site	Valladolid	Castilla Y Leon	Spain	47011
5	Investigative Site	London		United Kingdom	SW1E 6AU