Trial intelligence / Profile preview

SHP640 in Adenoviral Conjunctivitis

NCT02998554Phase 3

Key facts

Status: Terminated
Start: Mar 2017
Primary completion: May 2019
Countries: 2
Sponsor: Takeda
Modality: Orthosteric Ligands

Drugs: dexamethasone + povidone-iodine
Conditions: adenoviral conjunctivitis

Overview

Phase 3, randomised, double-blind trial in adenoviral conjunctivitis comparing SHP640 with Placebo (2 arms). Primary endpoint: Percentage of Participants With Clinical Resolution at Day 6. Started Mar 2017; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

SHP640
SHP640 (PVP-I 0.6% / Dexamethasone 0.1%) QID for 7 days
Placebo
Placebo QID for 7 days

Who it enrols

Patients of any age with suspected adenoviral conjunctivitis confirmed by clinical signs (bulbar conjunctival injection and watery discharge) or a positive AdenoPlus test. Excludes patients with other ocular infections, recent ocular surgery, or use of prohibited medications.

Endpoints

Primary

Percentage of Participants With Clinical ResolutionDay 6

Secondary

Percentage of Participants With Adenoviral EradicationDay 12
Absolute Change and Change From Baseline in Adenovirus Viral TiterDay 8
Percentage of Participants With Clinical ResolutionDay 12
Number of Participants With Individual Clinical Signs ScoreDay 12
Number of Participants With Global Clinical ScoreDay 12
Percentage of Participants With Modified Clinical ResolutionDay 12
Percentage of Participants With Expanded Clinical ResolutionDay 12
Percentage of Participants With Cross-Over InfectionDay 12

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