IDROFLOG OPHTHALMIC SOLUTION — 15 SINGLE-USE VIALS OF 0.5 ML

IDROFLOG® Ophthalmic Solution

Sodium Hyaluronate 2 mg/mL + Hydrocortisone Sodium Phosphate 10 µg/mL

Sterile Preservative-Free Single-Use Ophthalmic Vials

Medical Description

IDROFLOG® is a sterile, preservative-free ophthalmic solution formulated with 0.2% sodium hyaluronate (2 mg/mL) and 0.001% hydrocortisone sodium phosphate (10 µg/mL). It is designed to provide long-lasting lubrication of the ocular surface while helping control the low-grade inflammatory processes (para-inflammation) associated with Dry Eye Disease (DED) and other conditions involving ocular surface irritation. Clinical studies have demonstrated that combining sodium hyaluronate with an ultra-low concentration of hydrocortisone provides both tear film stabilization and targeted anti-inflammatory activity while maintaining an excellent ocular safety profile.

Active Ingredients

• Sodium Hyaluronate: 2 mg/mL (0.2%)
• Hydrocortisone Sodium Phosphate: 10 µg/mL (0.001%)

Mechanism of Action

Sodium Hyaluronate

Sodium hyaluronate is a naturally occurring glycosaminoglycan with exceptional water-retaining properties. It:

• Hydrates and lubricates the ocular surface.
• Stabilizes the tear film.
• Reduces tear evaporation.
• Protects corneal and conjunctival epithelial cells.
• Promotes epithelial healing and ocular surface recovery.
• Improves comfort during blinking.

Hydrocortisone Sodium Phosphate

Hydrocortisone sodium phosphate is a very low-dose corticosteroid that:

• Reduces ocular surface inflammation.
• Helps suppress inflammatory mediators involved in dry eye disease.
• Decreases conjunctival redness and irritation.
• Supports restoration of ocular surface homeostasis while minimizing steroid exposure due to its extremely low concentration.

Together, these ingredients provide both symptomatic relief and management of the inflammatory component of dry eye disease.

Indications

IDROFLOG® is indicated for:

• Dry Eye Disease (DED)
• Moderate ocular surface inflammation associated with dry eye
• Burning, stinging, and foreign body sensation
• Tear film instability
• Ocular surface irritation caused by environmental factors
• Post-cataract surgery dry eye symptoms
• Meibomian gland dysfunction–associated dry eye
• Ocular discomfort related to prolonged digital screen use
• Ocular dryness associated with topical glaucoma medications
• Supportive therapy following ophthalmic procedures when recommended by an eye care professional.

Clinical Benefits

• Provides rapid and prolonged ocular lubrication.
• Improves tear film stability.
• Reduces ocular surface inflammation.
• Relieves dryness, burning, itching, and irritation.
• Improves ocular comfort throughout the day.
• Supports corneal epithelial repair.
• Preservative-free formulation minimizes ocular surface toxicity.
• Single-use sterile vials reduce contamination risk.
• Suitable for long-term management under ophthalmologist supervision.

Adult Use

Suitable for adults experiencing:

• Dry Eye Disease
• Chronic ocular irritation
• Tear film instability
• Ocular discomfort following ophthalmic surgery
• Meibomian gland dysfunction
• Mild inflammatory ocular surface conditions as directed by an ophthalmologist.

Pediatric Use

Safety and use in children should be determined by an ophthalmologist. IDROFLOG® should only be used in pediatric patients when specifically prescribed by an eye care specialist.

Directions for Use

Unless otherwise directed by an ophthalmologist:

• Instill 1 drop into the affected eye(s) 2–4 times daily, or as prescribed.
• Wash hands before use.
• Open one single-use vial immediately before administration.
• Avoid touching the tip of the vial to the eye or surrounding tissues.
• Discard the vial immediately after use, even if solution remains.
• If using other ophthalmic medications, allow at least 10–15 minutes between products.

Contraindications

Do not use if:

• You are allergic to sodium hyaluronate, hydrocortisone, or any component of the formulation.
• You have untreated bacterial, fungal, or viral eye infections unless specifically instructed by an ophthalmologist.
• The vial is damaged or the solution appears contaminated.

Warnings and Precautions

• For ophthalmic use only.
• Do not inject or swallow.
• Remove contact lenses before instillation unless advised otherwise.
• Wait at least 15 minutes before reinserting contact lenses.
• Temporary blurred vision may occur after administration.
• Prolonged or inappropriate corticosteroid use should only occur under medical supervision.
• Seek immediate medical advice if eye pain, vision changes, severe redness, or persistent irritation develops.

Possible Side Effects

Most adverse effects are mild and temporary and may include:

• Mild burning or stinging
• Temporary blurred vision
• Eye irritation
• Foreign body sensation
• Increased tearing

Rarely:

• Allergic reactions
• Persistent redness
• Increased intraocular pressure with prolonged corticosteroid exposure (unlikely at this ultra-low concentration but should be monitored in long-term use).

Storage

• Store between 2°C and 25°C.
• Protect from excessive heat and direct sunlight.
• Keep out of reach of children.
• Do not use after the expiry date.
• Discard each vial immediately after opening.

Advantages of IDROFLOG®

• Preservative-free sterile formulation
• Single-use vials
• Dual-action hydration and anti-inflammatory therapy
• Supports ocular surface healing
• Excellent tolerability
• Suitable for chronic dry eye management under professional supervision
• Clinically evaluated in patients with Dry Eye Disease.

References:

1. ClinicalTrials.gov (National Institutes of Health) – Comparison of the Efficacy and Safety of Idroflog® for Dry Eye Disease.
2. PubMed Central (National Library of Medicine) – Dry Eye Para-Inflammation Management: Preclinical and Clinical Evidence on a Novel 0.2% Hyaluronic Acid-Based Tear Substitute with 0.001% Hydrocortisone Sodium Phosphate.
3. PubMed (National Library of Medicine) – Effectiveness of a New Active Tear Substitute Containing 0.2% Hyaluronic Acid and 0.001% Hydrocortisone on Signs and Symptoms of Dry Eye Disease.

Patient Disclaimer

This information is intended for educational purposes only and should not replace professional medical advice. IDROFLOG® should be used only as directed by an ophthalmologist or healthcare professional. Do not discontinue or modify your treatment without consulting your healthcare provider. Seek immediate medical attention if you experience severe eye pain, vision changes, signs of infection, or an allergic reaction.

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