Adenoviral Conjunctivitis

Sri Lanka participated in this global multi-country multi-center project. The study design was randomized (1:1) double‐masked, vehicle‐controlled, multi‐center, parallel group study with two **** treatment arms: ****** Ophthalmic Solution 0 (“******”) and ***** Vehicle (“Vehicle”). RemediumOne has managed 5 centers in Sri Lanka. Both ERC and Regulatory approvals were obtained within 18 weeks. Sri Lanka has recruited 88 participants within the recruitment period. The data quality of Sri Lanka was commended by the Sponsor and CRO. The retention rate was 96.3%. The participants adherence to the protocol was 98%.

The objective of this phase 2 study was to evaluate the clinical and microbiological efficacy and safety of ***** compared to vehicle for adenoviral conjunctivitis. Adults and children one year of age and older with diagnosis of adenoviral conjunctivitis in at least one eye based upon a positive adenovirus test result using the Aden-Detector Plus kit (*****). Subjects will be randomly assigned to receive either ***** or Vehicle.