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TheraTears® Lubricant Eye Drop
TheraTears lubricates and protects the ocular surface by supplementing natural tear film components, particularly lipids and aqueous components, to relieve dry eye symptoms.
TheraTears lubricates and protects the ocular surface by supplementing natural tear film components, particularly lipids and aqueous components, to relieve dry eye symptoms. Used for Dry eye disease / Keratoconjunctivitis sicca, Ocular surface irritation and discomfort.
At a glance
| Generic name | TheraTears® Lubricant Eye Drop |
|---|---|
| Sponsor | University of Waterloo |
| Drug class | Artificial tear / Ocular lubricant |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
TheraTears is a preservative-free lubricating eye drop formulated to mimic the composition of natural tears. It contains a balanced mixture of electrolytes and demulcents designed to stabilize the tear film and provide sustained lubrication to the cornea and conjunctiva. The formulation helps restore the protective barrier function of tears in patients with dry eye disease.
Approved indications
- Dry eye disease / Keratoconjunctivitis sicca
- Ocular surface irritation and discomfort
Common side effects
- Transient eye irritation
- Blurred vision
- Eye discomfort
Key clinical trials
- Hyaluronic Acid-containing Artificial Tears in Post-cataract Surgery Dry Eye Disease (PHASE4)
- Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy (PHASE4)
- Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease (PHASE3)
- A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief (PHASE3)
- Safety and Tolerability of Artificial Tears in Dry Eye Subjects (NA)
- Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects (NA)
- Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Acute Viral Conjunctivitis (PHASE2, PHASE3)
- A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products (DUNLIN) (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:
- TheraTears® Lubricant Eye Drop CI brief — competitive landscape report
- TheraTears® Lubricant Eye Drop updates RSS · CI watch RSS
- University of Waterloo portfolio CI