BioGlo™ Fluorescein Sodium Ophthalmic Strips USP

Manufacturer: HUB Pharmaceuticals, Inc.

Product Description:

BioGlo™ Fluorescein Sodium Ophthalmic Strips USP are sterile diagnostic strips impregnated with 1 mg of fluorescein sodium U.S.P. These strips are used in ophthalmic examinations to assess the ocular surface, diagnose corneal defects, and aid in contact lens fitting, dry eye evaluation, and applanation tonometry. The fluorescein sodium highlights corneal irregularities, epithelial damage, and tear film deficiencies when viewed under cobalt blue light.

Indications for Use:

• Contact Lens Fitting – Evaluates lens-to-cornea fitting and detects surface irregularities.
• Corneal Staining – Identifies corneal abrasions, ulcers, epithelial defects, and trauma.
• Applanation Tonometry – Essential for Goldmann tonometry, ensuring accurate intraocular pressure readings.
• Dry Eye Diagnosis & Ocular Surface Assessment –
  • Detects punctate epithelial erosions (PEE) in dry eye syndrome (DES).
  • Evaluates tear breakup time (TBUT) to assess tear film stability.
  • Assesses corneal/conjunctival integrity in ocular surface diseases, such as meibomian gland dysfunction (MGD), Sjögren’s syndrome, and exposure keratopathy.
• Post-Surgical Assessment – Helps monitor ocular healing after LASIK, PRK, corneal crosslinking, and cataract surgery.
• Foreign Body Detection – Aids in locating corneal/conjunctival foreign bodies or abrasions.

Directions for Use:

1. Moisten the impregnated tip of the BioGlo strip using one or two drops of sterile saline or irrigating solution before application.
2. Apply by gently touching the conjunctiva or fornix with the moistened tip.
3. Instruct the patient to blink several times to distribute the fluorescein evenly across the corneal surface.
4. Examine under a cobalt blue light to observe staining patterns and tear film stability.

Dry Eye & Ocular Surface Condition Assessment:

• Tear Breakup Time (TBUT) Test –
  • After applying fluorescein, the time from the last blink to the first appearance of dark spots in the tear film indicates TBUT.
  • TBUT <10 seconds suggests tear film instability and possible dry eye disease (DED).
• Ocular Surface Staining Score (Oxford or DEWS Scale) –
  • Determines severity of epithelial damage in dry eye, allergic conjunctivitis, or keratitis.
• Meibomian Gland Dysfunction (MGD) Evaluation –
  • Fluorescein staining helps visualize incomplete blinking or poor tear film distribution, common in MGD.

Storage & Handling:

• Store at room temperature.
• Ensure individual strips remain in their sterile packaging until use.
• Do not use if the strip packaging is damaged or previously opened.

Precautions & Warnings:

• For external ophthalmic use only.
• Not for injection or ingestion.
• Keep out of reach of children.
• Discard after single use to maintain sterility.

How Supplied:

• Dispenser carton containing 100 or 300 sterile strips.