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Systane Ultra Preservative Free
Systane Ultra Preservative Free is an artificial tear solution that lubricates and protects the ocular surface to relieve dry eye symptoms.
Systane Ultra Preservative Free is an artificial tear solution that lubricates and protects the ocular surface to relieve dry eye symptoms. Used for Dry eye disease / Keratoconjunctivitis sicca, Ocular surface irritation and discomfort.
At a glance
| Generic name | Systane Ultra Preservative Free |
|---|---|
| Also known as | Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3% |
| Sponsor | Laboratorios Sophia S.A de C.V. |
| Drug class | Artificial tear / Ocular lubricant |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
This ophthalmic lubricant contains a proprietary blend of demulcents and emollients that mimic natural tear composition, providing sustained hydration and protection to the cornea and conjunctiva. The preservative-free formulation reduces irritation from chemical preservatives, making it suitable for frequent use in patients with dry eye disease or those sensitive to preserved eye drops.
Approved indications
- Dry eye disease / Keratoconjunctivitis sicca
- Ocular surface irritation and discomfort
Common side effects
- Transient blurred vision
- Eye irritation or stinging
- Conjunctival hyperemia
Key clinical trials
- SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease (PHASE4)
- Quantifying Ocular Surface Aberrations After Tear Film Interventions (PHASE4)
- Systane® Ultra Preservative Free Lubricant Eye Drops (NA)
- Evaluation of the Safety and Tolerability of Ocular Lubricants (NA)
- Systane® Complete Preservative Free Lubricant Eye Drops (NA)
- Artificial Tears, Tear Lipids and Tear Film Dynamics (PHASE4)
- Systane® Hydration PF and Systane® Hydration Preserved (NA)
- Hyaluronic Acid-containing Artificial Tears in Post-cataract Surgery Dry Eye Disease (PHASE4)
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 Preservative Free CI brief — competitive landscape report
- Systane Ultra Preservative Free updates RSS · CI watch RSS
- Laboratorios Sophia S.A de C.V. portfolio CI