FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis

A Randomized, Masked, Vehicle-controlled Clinical Trial to Assess the Safety and Efficacy of PVP-I (0.4%)/Dexamethasone (0.1%) Ophthalmic Suspension (Foresight Biotherapeutics, Inc) in the Treatment of Acute Adenoviral Conjunctivitis

The objective of this study is to evaluate the efficacy of FST-100 (PVP-I 0.4% and dexamethasone 0.1%) Ophthalmic Suspension in the treatment of suspected acute adenoviral conjunctivitis.

Inclusion Criteria:

• Conjunctivitis within seven (7) days of initial ocular symptoms of redness and/or discharge.

• Clinical suspicion of adenoviral etiology.

• At least three (3) years of age.

• Subjects or their guardians capable of understanding the purpose and risks of the study, and able to give informed consent.

• Conjunctivitis diagnosis defined as presence of the two cardinal signs of acute conjunctivitis:

  1. conjunctival injection/inflammation, and
  2. conjunctival discharge/exudates.

Exclusion Criteria:

• Conjunctivitis longer than 7 days after initial ocular symptoms.
• Corneal ulcer, endophthalmitis, or any other confounding infection of the eye.
• Patients taking ocular anti-inflammatory medications on a chronic basis.
• Active herpes ocular infection.
• Known or suspected pregnancy.
• Known allergy to PVP-I.
• Known allergy to dexamethasone.
• Patients with a history of elevation in intraocular pressure as a result of steroid use ("steroid responders").