Dry Eye Clinical Trial
Official title:
Systane® Complete Preservative Free Lubricant Eye Drops
Verified date | March 2024 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 DED groups.
Status | Completed |
Enrollment | 68 |
Est. completion date | February 20, 2024 |
Est. primary completion date | February 20, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Aggarwal and Associates Limited | Brampton | Ontario |
Canada | Integra Eye Care | Burnaby | British Columbia |
Canada | Eyes on Sheppard Clinic | North York | Ontario |
Canada | University of Waterloo Centre for Contact Lens Research | Waterloo | Ontario |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean overall IDEEL-Symptom Bother(SB) score | The IDEEL-SB (Version 1) symptom bother module consists of 20 questions that assess general dry eye symptoms a subject experiences. The subject will be instructed to select a single response that best represents their answer. The Symptom Bother score is calculated as the mean value of the non-missing item scores 1-20 multiplied by 25. No statistical hypothesis is pre-specified for this endpoint. | Visit 3 (Day 30) |
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