ClinicalTrials.gg
CompletedNCT07412496Updated Oct 22, 2026

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

A Phase 2 interventional study of Topical Ocular BL1332 low dose and Topical Ocular BL1332 high dose in Pain, Postoperative, sponsored by Bausch & Lomb Incorporated. Completed at 15 sites in United States. Open to participants aged 18 Years to 58 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Phase 2, Interventional, and Treatment

Updated Oct 22, 2026Now CompletedFirst site in United States+5 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 58 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pain, Postoperative

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03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's enrollment of 130 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 223 studies on the registry; 5 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 41 (80%) have results posted.

First submitted after Bausch & Lomb Incorporated became part of Bausch Health Companies Inc..

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 58 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

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 or non-vasectomized males with partners of childbearing potential are not eligible unless they are using an effective method of 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    Topical Ocular BL1332 low dose

    BL1332 low dose ocular drop used 5x daily

    Drug: Topical Ocular BL1332 low dose

  • Experimental
    Topical Ocular BL1332 high dose

    BL1332 high dose ocular drop used 5x daily

    Drug: Topical Ocular BL1332 high dose

  • Placebo comparator
    BL1332 ophthalmic vehicle

    BL1332 vehicle ocular drop used 5x daily

    Drug: BL1332 Vehicle ophthalmic vehicle

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

06

What researchers measure

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

    Time frame: Assessed at a 24-hour period following PRK surgery

Secondary outcomes

  1. Ocular pain intensity postoperative period following PRK surgery

    Ocular pain intensity assessed using numeric pain rating scale 0 to 10, with 10 being the worst pain

    Time frame: Assessed at a 12-hour postoperative period following PRK surgery

07

Study locations

15 sites
  • Site 14
    Scottsdale, Arizona 85250, United States
  • Site 3
    Long Beach, California 90805, United States
  • Site 10
    Pasadena, California 91107, United States
  • Site 11
    San Diego, California 92122, United States
  • Site 15
    Davie, Florida 33324, United States
  • Site 13
    Brookline, Massachusetts 02445, United States
  • Site 5
    Bloomington, Minnesota 55420, United States
  • Site 8
    Amherst, New York 14228, United States
  • Site 9
    Fargo, North Dakota 58103, United States
  • Site 6
    West Fargo, North Dakota 58078, United States
  • Site 1
    Sioux Falls, South Dakota 57108, United States
  • Site 2
    Cedar Park, Texas 78613, United States
  • Site 12
    Draper, Utah 84020, United States
  • Site 4
    Salt Lake City, Utah 84107, United States
  • Site 7
    Lynchburg, Virginia 24502, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Completed
changed Oct 22, 2026
Sites
15 sites added — first site in United States
Show 15 added (15 United States)
  • Site 14 · Scottsdale, United States
  • Site 3 · Long Beach, United States
  • Site 10 · Pasadena, United States
  • Site 11 · San Diego, United States
  • Site 15 · Davie, United States
  • Site 13 · Brookline, United States
  • Site 5 · Bloomington, United States
  • Site 8 · Amherst, United States
  • Site 9 · Fargo, United States
  • Site 6 · West Fargo, United States
  • Site 1 · Sioux Falls, United States
  • Site 2 · Cedar Park, United States
  • Site 12 · Draper, United States
  • Site 4 · Salt Lake City, United States
  • Site 7 · Lynchburg, United States
Oct 22, 2026
Start date
Apr 2026→Mar 31, 2026 (actual)
Oct 22, 2026
Primary completion
Feb 2027→Oct 4, 2026 (actual)
Oct 22, 2026
Study completion
Feb 2027→Oct 4, 2026 (actual)
Oct 22, 2026
Enrollment
123 (estimated)→130 (actual)
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Not yet recruiting→Completed
    15 sites added — first site in United States
    Show 15 added (15 United States)
    • Site 14 · Scottsdale, United States
    • Site 3 · Long Beach, United States
    • Site 10 · Pasadena, United States
    • Site 11 · San Diego, United States
    • Site 15 · Davie, United States
    • Site 13 · Brookline, United States
    • Site 5 · Bloomington, United States
    • Site 8 · Amherst, United States
    • Site 9 · Fargo, United States
    • Site 6 · West Fargo, United States
    • Site 1 · Sioux Falls, United States
    • Site 2 · Cedar Park, United States
    • Site 12 · Draper, United States
    • Site 4 · Salt Lake City, United States
    • Site 7 · Lynchburg, United States
    Start date Apr 2026→Mar 31, 2026 (now actual)
    Primary completion Feb 2027→Oct 4, 2026 (now actual)
    Study completion Feb 2027→Oct 4, 2026 (now actual)
    Enrollment 123 (estimated)→130 (actual)
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07412496
Responsible party
Sponsor
First posted
Feb 17, 2026
Start date
Mar 31, 2026
Primary completion
Oct 4, 2026
Completion
Oct 4, 2026
Last update
Oct 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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