Trials / Terminated
TerminatedNCT02998554
Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Placebo
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 Placebo in the Treatment of Adenoviral Conjunctivitis
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 156 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if an investigational treatment is effective compared with placebo in the treatment of adults and children with adenoviral conjunctivitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHP640 | Instill 1 drop of SHP640 (PVP-I 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) (with a minimum of 2 hours between doses) for 7 days. |
| DRUG | Placebo | Instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days. |
Timeline
- Start date
- 2017-03-28
- Primary completion
- 2019-05-16
- Completion
- 2019-05-16
- First posted
- 2016-12-20
- Last updated
- 2021-06-09
- Results posted
- 2020-05-29
Locations
31 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02998554. Inclusion in this directory is not an endorsement.