Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo

Recruiting in Palo Alto (17 mi)

+162 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Shire

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

Inclusion Criteria

An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable).

Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guardian, or legally authorized representative(s) informed consent (and assent, if applicable) to participate in the study.

Participants of any age at Visit 1 (Note: participants less than (<) 3 months of age at Visit 1 must have been full-term, that is (ie,) greater than or equal to (>=) 37 weeks gestational age at birth).

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Treatment Details

Interventions

Placebo (Drug)
PVP-I 0.6% (Antibacterial)
SHP640 (Antibacterial)

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: SHP640Experimental Treatment1 Intervention

Participants will instill 1 drop of SHP640 (povidone-iodine \[PVP-I\] 0.6 percent \[%\] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.

Group II: PVP-I 0.6%Active Control1 Intervention

Participants will instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID for 7 days

Group III: PlaceboPlacebo Group1 Intervention

Participants will instill 1 drop of placebo ophthalmic solution in each eye 4 times QID for 7 days.