Trials / Terminated
TerminatedNCT02998541
Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and 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 PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 219 (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 and PVP-Iodine in the treatment of adults and children with adenoviral conjunctivitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHP640 | Participants will receive one drop of SHP640 (0.1 % dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days. |
| DRUG | PVP-I 0.6% | Participants will receive one drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days. |
| OTHER | Placebo | Participants will receive one drop of placebo ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days. |
Timeline
- Start date
- 2017-03-27
- Primary completion
- 2019-05-13
- Completion
- 2019-05-13
- First posted
- 2016-12-20
- Last updated
- 2021-06-14
- Results posted
- 2020-05-27
Locations
130 sites across 16 countries: United States, Australia, Austria, Canada, Estonia, France, Germany, Hungary, India, Israel, Italy, Peru, Poland, South Africa, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02998541. Inclusion in this directory is not an endorsement.