A Study to Evaluate the Use of Topical Ocular BL1332 for the Management of Postoperative Ocular Pain Following Photorefractive Keratectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topical Ocular BL1332 low dose, Topical Ocular BL1332 high dose, BL1332 Vehicle ophthalmic vehicle.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative. Basic parameters: 18 years — 58 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Vehicle-Controlled, Double-Masked, Parallel-Group Study to Evaluate the Use of Topical Ocular BL1332 for the Management of Postoperative Ocular Pain Following Photorefractive Keratectomy
Overview
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
- Drug Topical Ocular BL1332 low dose
Administered 5 times a day - Drug Topical Ocular BL1332 high dose
Administered 5 times a day - Drug BL1332 Vehicle ophthalmic vehicle
Administered 5 times a day
Primary outcome measures
- Ocular pain intensity following PRK surgery [Time frame: Assessed at a 24-hour period following PRK surgery]
Secondary outcome measures (1)
- Ocular pain intensity postoperative period following PRK surgery [Time frame: Assessed at a 12-hour postoperative period following PRK surgery]
Eligibility criteria
Inclusion criteria
- Male or female 18 to 58 years of age, inclusive.
- Scheduled to undergo PRK surgery and considered to be a good candidate per the Investigator's discretion.
- 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.
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07412496 · BL-RX01-BL1332-1201