A Study to Evaluate the Use of Topical Ocular BL1332 for the Management of Postoperative Ocular Pain Following Photorefractive Keratectomy

February 12, 2026 updated by: Bausch & Lomb Incorporated

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

123

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topical Ocular BL1332 low dose
BL1332 low dose ocular drop used 5x daily
Drug: Topical Ocular BL1332 low dose
Administered 5 times a day
Experimental: Topical Ocular BL1332 high dose
BL1332 high dose ocular drop used 5x daily
Drug: Topical Ocular BL1332 high dose
Administered 5 times a day
Placebo Comparator: BL1332 ophthalmic vehicle
BL1332 vehicle ocular drop used 5x daily
Drug: BL1332 Vehicle ophthalmic vehicle
Administered 5 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular pain intensity following PRK surgery
Time Frame: 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
Assessed at a 24-hour period following PRK surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular pain intensity postoperative period following PRK surgery
Time Frame: 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
Assessed at a 12-hour postoperative period following PRK surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BL-RX01-BL1332-1201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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