What side effects are associated with this type of intervention?

Common treatments for Dry Eye Syndrome, such as preservative-free artificial tears like Systane Ultra Preservative-Free, generally have minimal side effects. However, some patients may experience temporary blurred vision or mild eye irritation. In rare cases, there can be allergic reactions to the ingredients. Preservative-free formulations are preferred to avoid irritation and inflammation associated with preservatives, especially with frequent use. Other treatments, such as slow-release artificial tear inserts, may cause visual blurring and are difficult to place for some patients. Overall, these treatments are well-tolerated and effective for most patients.

What prior FDA approvals exist?

The FDA has approved several treatments for Dry Eye Syndrome that focus on lubricating and hydrating the eye surface. Notably, preservative-free formulations such as Systane Ultra Preservative-Free have been developed to reduce irritation and improve comfort for patients, especially those with frequent use needs. Other FDA-approved treatments include cyclosporine ophthalmic emulsion (Restasis), which increases tear production, and lifitegrast ophthalmic solution (Xiidra), which targets inflammation. Additionally, varenicline nasal spray has been approved to stimulate tear production. These treatments aim to alleviate symptoms and improve the quality of life for individuals with dry eye disease.

What other types of research exist?

Promising alternatives to Systane Ultra Preservative-Free for Dry Eye Syndrome patients include: 1) Propylene Glycol-Hydroxypropyl Guar (PG-HPG) nanoemulsion lubricant eye drops, which stabilize the tear film lipid layer and reduce tear evaporation. 2) Preservative-free artificial tears containing tamarind seed polysaccharide, which have shown improvements in corneal sensitivity and nerve plexus in glaucomatous patients. 3) Diquafosol and rebamipide eye drops, which are investigational but have shown promise in improving dry eye disease symptoms.

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Lubricant Eye Drops

Lubricant Eye Drops for Dry Eye Syndrome

N/A

Waitlist Available

Research Sponsored by Alcon Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 3 (day 30)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Systane Ultra PF eye drops in people with dry eyes and contact lens wearers who experience dryness. The drops work by adding moisture to the eyes, helping them feel more comfortable. Systane Ultra has been shown to be effective in alleviating symptoms of contact lens-related dry eye and is well tolerated by patients.

Who is the study for?

This trial is for individuals with mild to moderate dry eye symptoms, including those who wear contact lenses and experience discomfort due to dryness. Participants must understand and sign a consent form. The study will take place in Canada, Australia, and New Zealand.

What is being tested?

The trial is evaluating the performance and safety of Systane Ultra Preservative-Free (PF) lubricant eye drops for people with dry eyes or contact lens-related discomfort. It involves two groups: one with general dry eye syndrome and another consisting of contact lens wearers.

What are the potential side effects?

While not explicitly listed here, common side effects of lubricant eye drops like Systane Ultra PF may include temporary visual blurring, stinging or burning sensation in the eyes upon application.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 3 (day 30)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 3 (day 30)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 3 (day 30) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean overall IDEEL-Symptom Bother(SB) score - Group 1

Resultant overall CLDEQ-8 score - Group 2

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Systane Ultra Preservative-FreeExperimental Treatment1 Intervention

1-2 drops in each eye four times a day for 30 days

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Dry Eye Syndrome (DES) primarily work by lubricating and hydrating the ocular surface to stabilize the tear film and reduce tear evaporation. Products like Systane Ultra Preservative-Free (PF) contain ingredients that mimic natural tears, providing a protective barrier that helps to relieve symptoms such as burning, itching, and redness. These treatments are crucial for DES patients as they help maintain ocular surface integrity, improve comfort, and prevent further damage to the eye, thereby enhancing overall quality of life.

Effects of a 0.9% sodium chloride ophthalmic solution on the ocular surface of symptomatic contact lens wearers.