Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03004924 | Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo | PHASE3 | COMPLETED | 753 | — | — | Mar 29, 2017 | Oct 1, 2018 | Jun 9, 2021 | 163 | United States, Australia +11 |
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
| Arm | Type | Description |
|---|---|---|
| SHP640 | EXPERIMENTAL | 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. |
| PVP-I 0.6% | ACTIVE_COMPARATOR | Participants will instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID for 7 days |
| Placebo | PLACEBO_COMPARATOR | Participants will instill 1 drop of placebo ophthalmic solution in each eye 4 times QID for 7 days. |
| Name | Type | Description |
|---|---|---|
| SHP640 | DRUG | Instill 1 drop of SHP640 (povidone-iodine \[PVPI\] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days. |
| PVP-I 0.6% | DRUG | Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days. |
| Placebo | DRUG | Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days. |
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), guar...