Tear

Approved Indications:

• Dry Eye Syndrome (Keratoconjunctivitis Sicca): As an ocular lubricant to relieve eye dryness and irritation.
• Exposure Keratitis & Corneal Injury: Provides lubrication to protect the corneal surface in conditions such as lagophthalmos, neurotrophic keratitis, and exposure keratopathy.
• Post-Operative Ocular Care: Used after eye surgery (e.g., cataract extraction or LASIK) to alleviate dryness or irritation.
• Contact Lens Discomfort: Temporarily relieves eye irritation or dryness due to contact lens wear (as rewetting drops).
• Artificial Tear Substitute: Used in various ocular surface disorders with reduced tear production or poor tear film stability.

Clinically Accepted Off-label Uses:

• Dry Eye Associated with Autoimmune Disorders: Adjunctive therapy for Sjögren’s syndrome-related dry eyes.
• Allergic Conjunctivitis: Provides soothing relief when used alongside antihistamine drops.
• Radiation- or Chemotherapy-Induced Dry Eye: Used to improve eye lubrication in patients undergoing cancer therapies.
• Screen-Related Dry Eye (Computer Vision Syndrome): Lubrication in patients with tear evaporation due to prolonged screen exposure.

Adults & Elderly:

• Standard Dose: 1–2 drops in the affected eye(s) as needed, up to 6 times daily.
• Severe Dry Eye: May be used every 1–2 hours, depending on severity and product concentration.
• Post-Surgical Use: As directed by an ophthalmologist, typically 1–2 drops every 4–6 hours.

Pediatrics:

• Safe and effective when used under the supervision of a healthcare provider.
• Usual dosage: 1 drop in affected eye(s) 3–4 times daily or as needed.

Special Populations:

• Renal/Hepatic Impairment: No dose adjustment required (minimal systemic absorption).
• Pregnancy/Lactation: See section 5.

Administration Route:

• Ophthalmic Use Only. Apply drops directly into the lower conjunctival sac.
• Shake well if suspension formulation.
• Avoid touching the dropper tip to prevent contamination.

Duration of Use:

• Can be used long-term under medical supervision.
• If symptoms persist >72 hours, re-evaluation is advised.

Hypromellose acts as an inert, viscoelastic polymer that mimics natural tears. When applied to the eye, it forms a lubricating and protective film over the corneal and conjunctival surfaces. This film reduces friction, enhances tear film stability, and protects epithelial cells from desiccation. It stabilizes the precorneal tear film, prolonging tear retention time and alleviating symptoms of dryness and irritation. It does not exert pharmacologic effects but works by mechanical hydration and surface protection.

• Absorption: Negligible systemic absorption when administered ophthalmically.
• Distribution: Localized to ocular surfaces; does not enter systemic circulation.
• Metabolism: Not metabolized in the body; inert.
• Excretion: Eliminated via tear drainage or natural tear turnover; not systemically excreted.
• Onset of Action: Immediate lubrication upon application.
• Duration of Action: Depends on formulation; effects may last from 30 minutes to several hours.

• Pregnancy: Generally considered safe for use during pregnancy. There is no known risk of fetal harm due to lack of systemic absorption.
• Lactation: Safe for use while breastfeeding; not excreted into breast milk due to negligible systemic exposure.
• Data Status: No controlled human studies, but widely accepted safety in pregnancy/lactation due to non-pharmacologic nature. Use under medical supervision is advised.

• Primary Class: Ocular Lubricant
• Subclass: Artificial Tear / Ophthalmic Demulcent

• Hypersensitivity to Hypromellose or any component of the formulation
• Use of contaminated or expired product
• Infected or injured eyes (unless prescribed by a physician)

• Contamination Risk: Avoid touching the dropper tip to any surface including the eye.
• Contact Lens Users: Some formulations may contain preservatives (e.g., benzalkonium chloride) that can discolor or damage soft contact lenses. Remove lenses before use and wait at least 15 minutes before reinsertion.
• Allergic Reactions: Discontinue if eye redness, itching, or swelling occurs.
• Blurred Vision: Temporary blurring may occur after administration; avoid driving or operating machinery until vision clears.
• Long-Term Use Monitoring: In chronic dry eye or autoimmune eye conditions, regular ophthalmic evaluation is necessary.

Common Side Effects:

• Transient blurred vision
• Mild eye burning or stinging
• Foreign body sensation
• Eye redness or irritation

Uncommon but Serious:

• Allergic conjunctivitis
• Eye discharge or pain
• Swelling of eyelids
• Worsening of dry eye symptoms

Onset & Severity:

• Usually mild and self-limiting
• Adverse effects typically appear shortly after application and resolve within minutes
• Rare systemic side effects due to minimal absorption

• Drug-Drug: No significant systemic interactions due to negligible absorption.
• Ophthalmic Drug Interactions:
• May dilute or interfere with the absorption of concurrently applied eye drops. Administer other ophthalmic drugs at least 5–10 minutes apart.
• Preservative Interactions: Products containing benzalkonium chloride may interact with other eye medications or lenses.

• No major changes to regulatory status or guidelines in recent years.
• Clinical Practice Shift: Increased use in screen-induced dry eye, recognized by ophthalmic societies.
• Preservative-Free Formulations: Growing preference for preservative-free single-dose units to reduce long-term irritation and allergy risks, particularly in chronic users.

• Temperature: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C.
• Light Protection: Keep away from direct sunlight.
• Humidity: Store in a dry place; protect from moisture.
• Handling:
• Keep cap tightly closed.
• Avoid contamination of dropper tip.
• Refrigeration: Not required unless specified by manufacturer.
• Single-Use Units: Discard immediately after opening, even if unused.