Tears Naturale Eye Drops for Dry Eye Syndrome

Not yet recruiting at 4 trial locations
AC
Overseen ByAlcon Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

CT

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

I have mild to moderate dry eye disease.
* Able to attend all study visits as required as per protocol.
I meet a main requirement for the study.
See 3 more

Timeline for a Trial Participant

Screening/Baseline

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Participants receive Tears Naturale® Free or Tears Naturale® II lubricant eye drops as needed for 30 days

30 days
1 visit (in-person), 1 visit (telephone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days
1 visit (in-person)

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

Group I: Tears Naturale IIExperimental Treatment1 Intervention
Group II: Tears Naturale FreeExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials
739
Recruited
128,000+
Raquel C. Bono profile image

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott profile image

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 ( ...

Evaluation 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.

Tears 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.