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Also known as SHP640
FST-100 · 3 trials · 3 indications
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. |
| FST-100 | EXPERIMENTAL | - |
| FST-100 Vehicle | PLACEBO_COMPARATOR | - |
| FST-100 (Component #1) | EXPERIMENTAL | - |
| 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. |
| FST-100 | DRUG | FST-100 |
| FST-100 Vehicle | DRUG | FST-100 Vehicle |
| FST-100 (Component #1) | DRUG | 0.6% PVP-Iodine ophthalmic solution alone |
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...
FST-100 is an investigational small molecule being developed for the treatment of acute viral conjunctivitis and acute adenoviral conjunctivitis, which are eye infections causing inflammation of the conjunctiva. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
FST-100 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company listed on the stock exchange under the ticker symbol TAK. The drug is in Phase 2 clinical trials for the treatment of acute viral conjunctivitis and acute adenoviral conjunctivitis.
FST-100 is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory agencies. Two Phase 2 clinical trials for the treatment of acute viral conjunctivitis and acute adenoviral conjunctivitis have been completed.
FST-100 has been studied in two completed Phase 2 clinical trials. NCT01461954 evaluated FST-100 in acute viral conjunctivitis with 132 participants in the United States and Brazil. NCT01470664 evaluated FST-100 in acute adenoviral conjunctivitis with 176 participants in the United States and India.
FST-100 is a unique investigational drug candidate and no alternative names have been reported. It is being studied specifically for acute viral conjunctivitis and acute adenoviral conjunctivitis, and is not known to be identical to any other approved or investigational medication.