Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BOL-303224 | Registry Identifier | CAS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISV-403 | Experimental | 0.6% ISV-403 ophthalmic suspension |
|
| Vehicle | Placebo Comparator | Vehicle of ISV-403 ophthalmic suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISV-403 | Drug | Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Resolution of Baseline Bacterial Conjunctivitis | The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection | Day 5 +/- 1 day |
| Microbial Eradication of Baseline Bacterial Infection | Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline. | Day 5 +/- 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Resolution of Baseline Bacterial Conjunctivitis | The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection | Day 8 or 9 |
| Microbial Eradication of Baseline Bacterial Infection |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laura Trusso | Bausch & Lomb Incorporated | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32841261 | Derived | DeCory HH, Sanfilippo CM, Proskin HM, Blondeau JM. Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6. PLoS One. 2020 Aug 25;15(8):e0237603. doi: 10.1371/journal.pone.0237603. eCollection 2020. | |
| 20629472 |
Not provided
Not provided
957 Subjects with bacterial conjunctivitis were randomized to receive besifloxacin ophthalmic suspension or its vehicle, 11 subjects were discontinued due to failure to meet enrollment criteria or used disallowed medications.
First subject enrolled 6/5/2006, last patient exited on 11/7/2007. This study was conducted at multiple sites in the US.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ISV-403 | Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days. |
| FG001 | Vehicle | Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ISV-403 | Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days. |
| BG001 | Vehicle | Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Resolution of Baseline Bacterial Conjunctivitis | The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection | Modified intent to treat population, culture confirmed, as randomized | Posted | Number | Participants | Day 5 +/- 1 day |
|
8 days
Treatment emergent ocular adverse events occured in < 5% of the patients
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ISV-403 | Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Comstock | Bausch & Lomb Incorporated | (585) 338-6631 | timothy.comstock@bausch.com |
| ID | Term |
|---|---|
| C522124 | besifloxacin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vehicle | Drug | Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days. |
|
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
| Day 8 or 9 |
| Comstock TL, Paterno MR, Decory HH, Usner DW. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies. Clin Drug Investig. 2010;30(10):675-85. doi: 10.2165/11536720-000000000-00000. |
| 19323612 | Derived | Tepedino ME, Heller WH, Usner DW, Brunner LS, Morris TW, Haas W, Paterno MR, Comstock TL. Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis. Curr Med Res Opin. 2009 May;25(5):1159-69. doi: 10.1185/03007990902837919. |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Did not meet inclusion criteria |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Microbial Eradication of Baseline Bacterial Infection | Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline. | Modified Intent to treat population, culture confirmed, as randomized. | Posted | Number | Participants | Day 5 +/- 1 day |
|
|
|
| Secondary | Clinical Resolution of Baseline Bacterial Conjunctivitis | The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection | Modified intent to treat population, culture confirmed, as randomized | Posted | Number | Participants | Day 8 or 9 |
|
|
|
| Secondary | Microbial Eradication of Baseline Bacterial Infection | Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline. | Modified intent to treat population, culture confirmed, as randomized. | Posted | Number | Participants | Day 8 or 9 |
|
|
|
| 1 |
| 442 |
| 0 |
| 741 |
| EG001 | Vehicle | Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days. | 1 | 432 | 0 | 760 |
Sponsor has 45 days to review materials and provide comments back to the investigator.