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Sodium Hyaluronate Ophthalmic 0.4%
Sodium hyaluronate acts as a lubricating and hydrating agent that coats the ocular surface to relieve dry eye symptoms.
Sodium hyaluronate acts as a lubricating and hydrating agent that coats the ocular surface to relieve dry eye symptoms. Used for Dry eye syndrome / Keratoconjunctivitis sicca, Ocular surface irritation and discomfort.
At a glance
| Generic name | Sodium Hyaluronate Ophthalmic 0.4% |
|---|---|
| Also known as | Lagricel® Ofteno PF, PRO-037 |
| 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
Sodium hyaluronate is a naturally occurring polysaccharide that mimics the viscoelastic properties of tears. When applied topically to the eye, it forms a protective hydrophilic film on the cornea and conjunctiva, providing sustained lubrication, moisture retention, and protection against further irritation. This mechanism helps restore tear film stability and reduce symptoms associated with dry eye disease.
Approved indications
- Dry eye syndrome / Keratoconjunctivitis sicca
- Ocular surface irritation and discomfort
Common side effects
- Transient blurred vision
- Eye irritation or discomfort
- Mild conjunctival hyperemia
Key clinical trials
- Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution as Treatment for Dry Eye Disease. (PHASE2)
- Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagricel Ofteno® PF as Treatment for Dry Eye. (PHASE4)
- Clinical Trial for the Evaluation of Safety and Efficacy of Drop 0.4% (PHASE3)
- A Post-market Study to Evaluate the Effects of Sodium Hyaluronate Based Eye Drops in Patients Affected by Dry Eye Disease (NA)
- Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections (NA)
- Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF (PHASE1)
- Phase IV Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo After Photorefractive Keratectomy (PRK) (PHASE4)
- Dual-Polymer Hydroxypropyl Guar-and Hyaluronic Acid Lubricants in Rheumatoid Arthritis (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 |
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