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Systane® Ultra
Systane® Ultra is a Artificial tear lubricant Small molecule drug developed by The Mentholatum Company. It is currently FDA-approved for Dry eye syndrome / Keratoconjunctivitis sicca. Also known as: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Artificial Tears, polyethylene glycol 400, propylene glycol, Administration of Systane Ultra (Alcon).
Systane Ultra is an artificial tear lubricant that provides sustained ocular surface hydration and protection.
Systane Ultra is a small molecule lubricant eyedrop used to treat Dry Eye Syndrome and related conditions. It is a preservative-free lubricant eyedrop that has been clinically evaluated for its effectiveness in ocular surface staining.
At a glance
| Generic name | Systane® Ultra |
|---|---|
| Also known as | Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Artificial Tears, polyethylene glycol 400, propylene glycol, Administration of Systane Ultra (Alcon) |
| Sponsor | The Mentholatum Company |
| Drug class | Artificial tear lubricant |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
The formulation combines polyethylene glycol 400 and propylene glycol as active lubricating agents with a gelling system to create a protective film over the cornea and conjunctiva. This extended-release formulation is designed to provide longer-lasting relief from dry eye symptoms by maintaining moisture on the ocular surface and reducing tear evaporation.
Approved indications
- Dry eye syndrome / Keratoconjunctivitis sicca
Common side effects
- Blurred vision
- Eye irritation
- Ocular discomfort
Key clinical trials
- Systane® Ultra Preservative Free Lubricant Eye Drops (NA)
- Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface. (PHASE1)
- Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease (PHASE3)
- Symptom Response in Normal and Dry Eye Patients Secondary to Application of a Menthol-Containing Eyedrop (Rohto® Hydra) (PHASE4)
- Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Ultra Preservative Free (087LATAMFIV) (PHASE4)
- Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects (PHASE1)
- Tear Lipid Layer Thickness Changes With Use of Emollient and Non-Emollient Eye Drops (NA)
- Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Systane® Ultra CI brief — competitive landscape report
- Systane® Ultra updates RSS · CI watch RSS
- The Mentholatum Company portfolio CI
Frequently asked questions about Systane® Ultra
What is Systane® Ultra?
How does Systane® Ultra work?
What is Systane® Ultra used for?
Who makes Systane® Ultra?
Is Systane® Ultra also known as anything else?
What drug class is Systane® Ultra in?
What development phase is Systane® Ultra in?
What are the side effects of Systane® Ultra?
Related
- Drug class: All Artificial tear lubricant drugs
- Manufacturer: The Mentholatum Company — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Dry eye syndrome / Keratoconjunctivitis sicca
- Also known as: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Artificial Tears, polyethylene glycol 400, propylene glycol, Administration of Systane Ultra (Alcon)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing