Pain, Postoperative
Conditions
Brief summary
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.
Interventions
DRUGTopical Ocular BL1332 low dose
Administered 5 times a day
DRUGTopical Ocular BL1332 high dose
Administered 5 times a day
DRUGBL1332 Vehicle ophthalmic vehicle
Administered 5 times a day
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 58 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female 18 to 58 years of age, inclusive. 2. Scheduled to undergo PRK surgery and considered to be a good candidate per the Investigator's discretion. 3. Provide written informed consent (signed and dated informed consent form \[ICF\]) using the Institutional Review Board (IRB)-approved ICF prior to any study-related procedures. 4. Able to read, understand, and voluntarily sign the ICF and, if applicable, provide written authorization per local privacy regulations.
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. 1. 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. 2. Participation in a clinical trial within 30 days prior to Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular pain intensity following PRK surgery | Assessed at a 24-hour period following PRK surgery | Ocular pain intensity assessed using numeric pain rating scale 0 to 10, with 10 being the worst pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular pain intensity postoperative period following PRK surgery | Assessed at a 12-hour postoperative period following PRK surgery | Ocular pain intensity assessed using numeric pain rating scale 0 to 10, with 10 being the worst pain |
Contacts
CONTACTCelia Busby
Outcome results
None listed