Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo
Overview
| Condition | Adenoviral Conjunctivitis |
| Treatments | SHP640, PVP-I 0.6%, Placebo |
| Phase | Phase 3 |
| Sponsor | Shire |
| Start Date | March 2017 |
| End Date | May 2018 |
| Trial Size | 930 |
| Trial Identifier | NCT02998541 |
Summary
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 adenoviral conjunctivitis.Study Design
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Primary Purpose | Treatment |
| Masking | Double (Participant, Investigator) |
Study Arms
- Experimental: SHP640
- Instill 1 drop of SHP640 (0.1 percent [%] Dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
- Intervention: Drug: SHP640
- Active Comparator: PVP-I 0.6%
- Instill 1 drop of PVP-I ophthalmic solution in each eye QID for 7 days.
- Intervention: Drug: PVP-I 0.6%
- Placebo Comparator: Placebo
- Instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
- Intervention: Drug: Placebo
Eligibility Critera
Inclusion Criteria:- Subjects of any age at Visit 1.
- Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.
- Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye (the same eye as the AdenoPlus positive eye) confirmed by the presence of the following minimal clinical signs and symptoms in that same eye.
- Be willing to discontinue contact lens wear for the duration of the study.
- Have a Best Corrected Visual Acuity (BCVA) of 0.60 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
- Other protocol defined inclusion criteria may apply
- Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
- Prior enrollment in a FST100 or SHP640 clinical study.
- Subjects who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
- Have a history of ocular surgical intervention within ≤ 6 months prior to Visit 1 or planned for the period of the study.
- Have a preplanned overnight hospitalization during the period of the study.
- Have active or history of ocular herpes.
- Have at enrollment or within ≤30 days of Visit 1, a clinical presentation more consistent with the diagnosis of non-infectious conjunctivitis (except presumed seasonal/perennial allergic conjunctivitis) or non-adenoviral ocular infection (eg, bacterial, fungal, acanthamoebal, or other parasitic).
- Other protocol defined exclusion criteria may apply
Additional Information
| Official Title | A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis |