A Study to Evaluate the Use of Topical Ocular BL1332 for the Management of Postoperative Ocular Pain Following Photorefractive Keratectomy
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
1 other identifier
interventional
123
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2026
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
February 17, 2026
February 1, 2026
10 months
January 26, 2026
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Ocular pain intensity postoperative period following PRK surgery
Assessed at a 12-hour postoperative period following PRK surgery
Study Arms (3)
Topical Ocular BL1332 low dose
EXPERIMENTALBL1332 low dose ocular drop used 5x daily
Topical Ocular BL1332 high dose
EXPERIMENTALBL1332 high dose ocular drop used 5x daily
BL1332 ophthalmic vehicle
PLACEBO COMPARATORBL1332 vehicle ocular drop used 5x daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2026
First Posted
February 17, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share