Systane® Complete Preservative Free Lubricant Eye Drops

Not Applicable

Completed

Conditions: Dry Eye

Interventions: Other: Propylene glycol solution/drops

Registration Number: NCT05932225

Lead Sponsor: Alcon Research

Brief Summary: The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Complete Preservative Free (PF) lubricant eye drops in subjects experiencing dry eye symptoms. Statistical analyses will be presented overall and by Dry Eye Disease (DED) group.

Detailed Description: Subjects will participate in the study for approximately 30 days, with a Screening/Baseline visit scheduled on Day 1, a phone call scheduled on Day 15 ± 2 (Visit 2) and a follow-up visit scheduled on Day 30 ± 2 (Visit 3). Subjects will be asked to complete the Impact of Dry Eye on Everyday Life - Symptom Bother \[IDEEL-SB\]) questionnaire on Day 1 and Visit 3. In addition, subjects will be instructed to document Systane Complete PF dosing information on a daily basis using a subject diary.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 71

Inclusion Criteria

Subject must be able to understand and sign an informed consent form
Subject with mild to moderate dry eye
Other protocol-defined inclusion criteria may apply

Exclusion Criteria

Has suffered any ocular injury to either eye in the past 3 months prior to screening.
Has undergone any other ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned during the study.
Other protocol-defined exclusion criteria may apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Systane Complete Preservative-Free	Propylene glycol solution/drops	1-2 drops in each eye four times a day for 30 days

Primary Outcome Measures

Name	Time	Method
Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group	Baseline (Day 1 pretreatment), Day 30	The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, the subject selected a single response for both eyes, where 0="None of the time" (Q1) or "I did not have this symptom/Not Applicable" (Q2-20) to 4="All of the time" (Q1) or "Very Much" (Q2-20). The overall Symptom Bother score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25, for an overall resultant score ranging from 0 to 100. Higher scores indicate greater symptom bother. No statistical hypothesis was pre-specified for this endpoint.
Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - All Subjects	Baseline (Day 1 pretreatment), Day 30	The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, the subject selected a single response for both eyes, where 0="None of the time" (Q1) or "I did not have this symptom/Not Applicable" (Q2-20) to 4="All of the time" (Q1) or "Very Much" (Q2-20). The overall Symptom Bother score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25, for an overall resultant score ranging from 0 to 100. Higher scores indicate greater symptom bother. No statistical hypothesis was pre-specified for this endpoint.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (4): Eyes on Sheppard Clinic
🇨🇦
North York, Ontario, Canada
University of Waterloo Centre for Contact Lens Research
🇨🇦
Waterloo, Ontario, Canada
Aggarwal and Associates Limited
🇨🇦
Brampton, Ontario, Canada
Integra Eye Care
🇨🇦
Burnaby, British Columbia, Canada