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
Not provided
Not provided
Not provided
Not provided
This is a multicenter, double-masked study to evaluate the use of Topical Ocular BL1332 for the management of post-operative pain after Photorefractive Keratectomy (PRK) surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Ocular BL1332 low dose | Experimental | BL1332 low dose ocular drop used 5x daily |
|
| Topical Ocular BL1332 high dose | Experimental | BL1332 high dose ocular drop used 5x daily |
|
| BL1332 ophthalmic vehicle | Placebo Comparator | BL1332 vehicle ocular drop used 5x daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Ocular BL1332 low dose | Drug | Administered 5 times a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular pain intensity following PRK surgery | Ocular pain intensity assessed using numeric pain rating scale 0 to 10, with 10 being the worst pain | Assessed at a 24-hour period following PRK surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular pain intensity postoperative period following PRK surgery | Ocular pain intensity assessed using numeric pain rating scale 0 to 10, with 10 being the worst pain | Assessed at a 12-hour postoperative period following PRK surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from this study. All criteria are evaluated at Screening unless otherwise specified.
Women of childbearing potential or non-vasectomized males with partners of childbearing potential are not eligible unless they are using an effective method of contraception and agree to use an effective method of contraception until at least 30 days after study treatment.
a. Male who is unwilling to agree to use at least 1 medically accepted form of birth control with female partner of childbearing potential.
Participation in a clinical trial within 30 days prior to Screening.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celia Busby | Contact | 9453277624 | celia.busby@bausch.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Topical Ocular BL1332 high dose |
| Drug |
Administered 5 times a day |
|
| BL1332 Vehicle ophthalmic vehicle | Drug | Administered 5 times a day |
|
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided