Tears Naturale Eye Drops for Dry Eye Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness and safety of Tears Naturale® Free and Tears Naturale® II eye drops for individuals with dry eye symptoms. Participants will use one of these eye drops as needed for about a month to assess symptom improvement. The trial suits those with mild to moderate dry eye issues who agree to use only the study's eye drops during this period. Individuals with recent eye injuries or surgeries may not be eligible. As an unphased trial, this study provides a unique opportunity to contribute to understanding the effectiveness of these treatments for dry eye symptoms.
Do I need to stop taking my current medications for the trial?
You will need to stop using any artificial tear supplements you currently use and only use the study eye drops during the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that Tears Naturale Free and Tears Naturale II are safe for most people. U.S. safety rules do not consider Tears Naturale Free dangerous. As a simple eye lubricant, it keeps eyes moist without harmful chemicals. If side effects occur, they are usually mild, such as slight eye irritation.
Tears Naturale II is also well-tolerated. Most people experience no issues, though some might feel brief stinging or blurry vision. These effects are temporary and not serious.
Both treatments are popular over-the-counter options for dry eyes and have been used safely by many people.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Tears Naturale Free and Tears Naturale II because these eye drops offer preservative-free options for managing dry eye syndrome, a condition often treated with lubricating eye drops that may contain preservatives. Unlike standard treatments that might irritate sensitive eyes due to preservatives, both Tears Naturale variations aim to provide relief without this potential side effect. Additionally, the flexibility in dosing—using one to two drops as needed—allows for personalized care, accommodating varying degrees of dryness throughout the day. This approach could enhance comfort and adherence for individuals experiencing dry eye symptoms.
What is the effectiveness track record for Tears Naturale eye drops in treating dry eye syndrome?
This trial will compare Tears Naturale Free and Tears Naturale II for treating dry eye syndrome. Research has shown that artificial tears, such as Tears Naturale Free and Tears Naturale II, can relieve dry eye symptoms. A review found that using these drops regularly, about four times a day, can make eyes feel more comfortable and less dry. Studies also suggest that preservative-free artificial tears, like Tears Naturale Free, might be more comfortable for some people, although strong evidence does not confirm they work better. Overall, these drops help restore the eye's natural moisture and reduce irritation, making them a popular choice for treating dry eyes.56789
Who Is on the Research Team?
Clinical Trial Lead, Dry Eye
Principal Investigator
Alcon Research, LLC
Are You a Good Fit for This Trial?
This trial is for people with mild to moderate dry eye who can attend all study visits, are able to give consent in English or French, and are willing to stop using their usual artificial tears and use only the study drops during the trial.Inclusion Criteria
Timeline for a Trial Participant
Screening/Baseline
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Tears Naturale® Free or Tears Naturale® II lubricant eye drops as needed for 30 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tears Naturale Free
- Tears Naturale II
Trial Overview
The study compares two types of lubricating eye drops—Tears Naturale Free and Tears Naturale II—to see how well they work and how safe they are for treating dry eye symptoms. Participants will be randomly assigned to one of these treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
One to two drops of artificial tears per eye as needed for 30 days (-2/+5 days)
One to two drops of artificial tears per eye as needed for 30 days (-2/+5 days)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alcon Research
Lead Sponsor
Raquel C. Bono
Alcon Research
Chief Medical Officer since 2022
MD from Harvard Medical School
David Endicott
Alcon Research
Chief Executive Officer since 2018
MBA from University of Southern California
Citations
Over the counter (OTC) artificial tear drops for dry eye syndrome
Nevertheless, we found that 0.2% polyacrylic acid‐based artificial tears were consistently more effective at treating dry eye symptoms than 1.4% polyvinyl ...
Artificial Tears: A Systematic Review - PMC - NIH
There is good evidence that artificial tears improve symptoms of dry eye disease within a month of regular use, applied about four times a day.
Effectiveness of using preservative-free artificial tears ...
Evidence proving that preservative-free artificial tears are more effective than preserved artificial tears is lacking. Keywords: Dry eye ...
Comparison of Two Preservative-Free Artificial Tears with ...
Dry eye signs, symptoms, and QoL measures improved continuously in both groups, with the SH-CB-TG group showing significantly improved QoL globally at Day 90 ( ...
5.
ctv.veeva.com
ctv.veeva.com/study/evaluation-of-tears-naturale-r-free-and-tears-naturale-r-ii-lubricant-eye-dropsEvaluation of Tears Naturale® Free and Tears Naturale® II ...
The purpose of this post-market clinical follow-up (PMCF) study is to describe the effectiveness and safety of Tears Naturale® Free and Tears ...
Safety Data Sheet - acc. to OSHA HCS (29 CFR 1910.1200)
The product is not classified as hazardous according to OSHA GHS regulations within the United States. Hazard pictograms Not Regulated.
7.
imgcdn.mckesson.com
imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9ALABO_ALCON_TEARS_DRP_EYE_0.5_PERCENT_15ML_2025.pdfTears Naturale FREE® Lubricant Eye Drops
Reactivity: Hazardous reactions will not occur under normal conditions. Page 3. Tears Naturale FREE® Lubricant Eye Drops. Safety Data Sheet.
TEARS NATURALE® eye drops, solution
TEARS NATURALE is a slightly viscous solution that acts as an artificial tear. It is used to treat dry eyes caused by a lack of tears in the eye(s).
Tears Naturale Free Side Effects
Learn about the side effects of Tears Naturale Free (ocular lubricant), from common to rare, for consumers and healthcare professionals.
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