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NCT Number: NCT07412496

A 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.

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Key information

Age range

18 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical Ocular BL1332 low dose

Drug

Administered 5 times a day

Topical Ocular BL1332 high dose

Drug

Administered 5 times a day

BL1332 Vehicle ophthalmic vehicle

Drug

Administered 5 times a day

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Celia Busby

CONTACT

[email protected]

9453277624

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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