Pain, PostoperativePhase 2NCT07412496
A Study to Evaluate the Use of Topical Ocular BL1332 for the Management of Postoperative Ocular Pain Following Photorefractive Keratectomy
A Phase 2 study testing Topical Ocular BL1332 low dose and Topical Ocular BL1332 high dose in people with Pain, Postoperative, run by Bausch & Lomb Incorporated at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 58 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Topical Ocular BL1332 low dose and Topical Ocular BL1332 high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 15 sitesUnited States
- Study dates
- 31 Mar 2026to 4 Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Site 8
Amherst, New York, 14228
Site 5
Bloomington, Minnesota, 55420
Site 13
Brookline, Massachusetts, 02445
Site 2
Cedar Park, Texas, 78613
Site 15
Davie, Florida, 33324
Site 12
Draper, Utah, 84020
Site 9
Fargo, North Dakota, 58103
Site 3
Long Beach, California, 90805
Site 7
Lynchburg, Virginia, 24502
Site 10
Pasadena, California, 91107
Site 4
Salt Lake City, Utah, 84107
Site 11
San Diego, California, 92122
Site 14
Scottsdale, Arizona, 85250
Site 1
Sioux Falls, South Dakota, 57108
Site 6
West Fargo, North Dakota, 58078
About this study
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
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.
- Conditions
- Pain, Postoperative
- Being tested
- Topical Ocular BL1332 low dose, Topical Ocular BL1332 high dose, BL1332 Vehicle ophthalmic vehicle
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Ocular BL1332 low doseDrug
Administered 5 times a day
Topical Ocular BL1332 high doseDrug
Administered 5 times a day
BL1332 Vehicle ophthalmic vehicleDrug
Administered 5 times a day
| Study group | Role | What they receive |
|---|---|---|
| Topical Ocular BL1332 low dose | Experimental | BL1332 low dose ocular drop used 5x daily Receives: Drug: Topical Ocular BL1332 low dose |
| Topical Ocular BL1332 high dose | Experimental | BL1332 high dose ocular drop used 5x daily Receives: Drug: Topical Ocular BL1332 high dose |
| BL1332 ophthalmic vehicle | Placebo comparator | BL1332 vehicle ocular drop used 5x daily Receives: Drug: BL1332 Vehicle ophthalmic vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular pain intensity following PRK surgery
Ocular pain intensity assessed using numeric pain rating scale 0 to 10, with 10 being the worst pain
Measured: 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
Measured: Assessed at a 12-hour postoperative period following PRK surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start31 Mar 2026
- Primary completion4 Oct 2026
- Study completion4 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412496
- Sponsor's protocol ID
- BL-RX01-BL1332-1201
- Status last verified
- Oct 2026
- First submitted
- 26 Jan 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07412496
- Acronym / sponsor ID
- BL-RX01-BL1332-1201
- Conditions
- Pain, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 4 Oct 2026 (actual)
- Study completion
- 4 Oct 2026 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical Ocular BL1332 low dose | Experimental | Drug: Topical Ocular BL1332 low doseBL1332 low dose ocular drop used 5x daily |
| Topical Ocular BL1332 high dose | Experimental | Drug: Topical Ocular BL1332 high doseBL1332 high dose ocular drop used 5x daily |
| BL1332 ophthalmic vehicle | Placebo comparator | Drug: BL1332 Vehicle ophthalmic vehicleBL1332 vehicle ocular drop used 5x daily |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
- Participation in a clinical trial within 30 days prior to Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Ocular BL1332 low doseAdministered 5 times a day | Drug | Topical Ocular BL1332 low dose |
| Topical Ocular BL1332 high doseAdministered 5 times a day | Drug | Topical Ocular BL1332 high dose |
| BL1332 Vehicle ophthalmic vehicleAdministered 5 times a day | Drug | BL1332 ophthalmic vehicle |
Primary outcome
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
1 secondary outcome
Ocular pain intensity postoperative period following PRK surgery
Time frame: Assessed at a 12-hour postoperative period following PRK surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical Ocular BL1332 low dose and Topical Ocular BL1332 high dose in people with Pain, Postoperative, run by Bausch & Lomb Incorporated at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular pain intensity following PRK surgery (time frame: Assessed at a 24-hour period following PRK surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.