Ocular PainPhase 1NCT06978244
A Study to Assess Safety, Tolerability, and Pharmacokinetics of Ascending Concentrations of Topical Ocular BL1332 in Healthy Volunteers
A Phase 1 study testing BL1332 ophthalmic solution in people with Ocular Pain, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
Single-Center, Phase 1 study to assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs) Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Pain
- What is being tested?
- BL1332 ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2025to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent prior to conduct of any study-related assessment
- Male and female subjects ≥18 to ≤50 years of age and in good health, as assessed by the Investigator from past medical history, physical examination, and laboratory tests at Screening
- Vital signs assessed in the sitting position after the subject has rested for at least 3 minutes, within the following ranges at Screening and at the Baseline Visit:
- Oral body temperature ≥35.0°C and ≤37.5°C
- Systolic blood pressure ≥90 and <140 mmHg
- Diastolic blood pressure ≥50 and <90 mmHg
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- Pulse rate ≥40 and ≤100 bpm
- Body weight ≥50 kg
- Body mass index (BMI) between 18.0 and 30.0 kg/m2 [BMI = Body weight (kg) / Height (m)2]
- Corrected visual acuity of 20/40 (Snellen) or better in each eye at Screening
- Able to communicate well with the Investigator and to understand and comply with the requirements of the study
Who cannot join
- Women of childbearing potential (WOCBP) 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.
- Women are considered of childbearing potential unless they have undergone permanent sterilization (such as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal occlusion) or have been amenorrheic for ≥12 months without an alternative medical cause.
- Effective methods of contraception include systemic hormonal (inhibition of ovulation not primary mode of action) containing progestins only; single barrier male or female condom with or without spermicide or cap; diaphragm; sponge with spermicide; double barrier (male condom combined with one of the barrier methods); or intrauterine device
- Women who are pregnant, lactating, or breastfeeding are excluded.
- Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator and based on the content of the Investigator's Brochure (IB), preclude the safe administration of IP or safe participation in this study
- Use of gabapentinoids or opioids within 30 days prior to Screening
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- Use of topical capsaicin within 30 days prior to Screening
- Chronic use (defined as ≥15 days/month for 3 months prior to Screening) of acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) or anticipated regular (daily) use during the study
- Chronic use of medications or dietary supplements (over-the-counter and/or prescription) that have not been stable for ≥14 days prior to Screening or any anticipated change in the chronic medication regimen
- Reported use of tobacco products within 3 months prior to Screening and/or urine cotinine level consistent with use of tobacco product (not passive exposure) at Screening
- History of use of marijuana/cannabinoid (CBD) or illicit substances including cocaine, heroin, methamphetamine, hallucinogens, or non-prescribed opioids within 3 months prior to Screening
- Use of systemic corticosteroids, anticoagulants, or migraine medications such as ergotamine, calcitonin gene-related peptide (CGRP) antagonists within 30 days prior to the Baseline Visit
- Use of cytochrome P450 3A4 (CYP3A4) or CYP3A5 inhibitors or inducers within 2 weeks prior to the Baseline Visit
- History of any ocular surgery or ocular laser intervention within 6 months prior to Screening
- History of any chronic eye disease other than refractive error, incipient cataract, strabismic amblyopia, or anisometropic amblyopia. Subjects with a history of acute eye disease (such as infection, corneal abrasion, or allergy) within 6 months prior to Screening may be eligible if the disease is not currently active.
- Any currently active ocular condition that requires use of topical eye drops
- Contact lens use within 2 weeks prior to Screening and throughout the study
- Consumption of alcohol within 48 hours prior to the Baseline Visit and throughout the study
- Donation or loss of ≥450 mL of blood within 8 weeks prior to Screening or longer, if required by local regulation
- Hemoglobin <11.0 g/dL at Screening
- Current or past history of human immunodeficiency virus (HIV) disease and/or hepatitis
- Past participation in a clinical study within 30 days prior to Screening
Trial locations and contacts
1 site in 1 country.
About this study
Single-Center, Phase 1 study to assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)
Read the detailed description
To assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)
- Conditions
- Ocular Pain
- Being tested
- BL1332 ophthalmic solution, BL1332 ophthalmic vehicle
- Medical subject headings
- Eye Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL1332 ophthalmic solutionDrug
Both arms taken four times a day for 1 day
BL1332 ophthalmic vehicleDrug
Both arms taken four times a day for 1 day
| Study group | Role | What they receive |
|---|---|---|
| BL1332 ophthalmic solution (0.06%, 0.15%, and 0.30% concentrations) | Experimental | BL1332 ophthalmic solution (0.06%, 0.15%, and 0.30% concentrations) administered as topical ocular drops Receives: Drug: BL1332 ophthalmic solution |
| BL1332 vehicle | Placebo comparator | BL1332 vehicle administered as topical ocular drops Receives: Drug: BL1332 ophthalmic vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLTs (dose-limiting toxicities)
To assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)
Measured: Approximately 6 months
Incidence of treatment-emergent AEs (TEAEs)
To assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)
Measured: Approximately 6 months
Treatment-emergent changes in systemic and ocular safety assessments
To assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)
Measured: Approximately 6 months
PK profiles and following parameter, where data allow (Cmax)
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
Measured: Approximately 6 months
PK profiles and following parameter, where data allow ( Tmax)
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
Measured: Approximately 6 months
PK profiles and following parameter, where data allow (Ctau)
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
Measured: Approximately 6 months
PK profiles and following parameter, where data allow (Tlast)
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
Measured: Approximately 6 months
PK profiles and following parameter, where data allow ( AUClast)
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
Measured: Approximately 6 months
PK profiles and following parameter, where data allow (AUCtau)
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
Measured: Approximately 6 months
PK profiles and following parameter, where data allow (AUCinf)
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
Measured: Approximately 6 months
PK profiles and following parameter, where data allow (ke1)
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
Measured: Approximately 6 months
PK profiles and following parameter, where data allow (t1/2)
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
Measured: Approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start29 Jul 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular PainStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT06978244
- Sponsor's protocol ID
- BL-RX01-BL1332-1101
- Status last verified
- Jan 2026
- First submitted
- 8 May 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Safety, Tolerability, and Pharmacokinetics of Ascending Concentrations of Topical Ocular BL1332 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06978244
- Acronym / sponsor ID
- BL-RX01-BL1332-1101
- Conditions
- Ocular Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 18 May 2025 (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.
Single-Center, Phase 1 study to assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)
Detailed description
To assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BL1332 ophthalmic solution (0.06%, 0.15%, and 0.30% concentrations) | Experimental | Drug: BL1332 ophthalmic solutionBL1332 ophthalmic solution (0.06%, 0.15%, and 0.30% concentrations) administered as topical ocular drops |
| BL1332 vehicle | Placebo comparator | Drug: BL1332 ophthalmic vehicleBL1332 vehicle administered as topical ocular drops |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Written informed consent prior to conduct of any study-related assessment
- Male and female subjects ≥18 to ≤50 years of age and in good health, as assessed by the Investigator from past medical history, physical examination, and laboratory tests at Screening
- Vital signs assessed in the sitting position after the subject has rested for at least 3 minutes, within the following ranges at Screening and at the Baseline Visit:
- Body weight ≥50 kg
- Body mass index (BMI) between 18.0 and 30.0 kg/m2 [BMI = Body weight (kg) / Height (m)2]
Key exclusion criteria (22 listed)
- Women of childbearing potential (WOCBP) 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.
- Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator and based on the content of the Investigator's Brochure (IB), preclude the safe administration of IP or safe participation in this study
- Use of gabapentinoids or opioids within 30 days prior to Screening
- Use of topical capsaicin within 30 days prior to Screening
- Chronic use (defined as ≥15 days/month for 3 months prior to Screening) of acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) or anticipated regular (daily) use during the study
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 |
|---|---|---|
| BL1332 ophthalmic solutionBoth arms taken four times a day for 1 day | Drug | BL1332 ophthalmic solution (0.06%, 0.15%, and 0.30% concentrations) |
| BL1332 ophthalmic vehicleBoth arms taken four times a day for 1 day | Drug | BL1332 vehicle |
Primary outcome
Incidence of DLTs (dose-limiting toxicities)
Time frame: Approximately 6 months
To assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)
Incidence of treatment-emergent AEs (TEAEs)
Time frame: Approximately 6 months
To assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)
Treatment-emergent changes in systemic and ocular safety assessments
Time frame: Approximately 6 months
To assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)
PK profiles and following parameter, where data allow (Cmax)
Time frame: Approximately 6 months
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
PK profiles and following parameter, where data allow ( Tmax)
Time frame: Approximately 6 months
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
PK profiles and following parameter, where data allow (Ctau)
Time frame: Approximately 6 months
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
PK profiles and following parameter, where data allow (Tlast)
Time frame: Approximately 6 months
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
PK profiles and following parameter, where data allow ( AUClast)
Time frame: Approximately 6 months
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
PK profiles and following parameter, where data allow (AUCtau)
Time frame: Approximately 6 months
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
PK profiles and following parameter, where data allow (AUCinf)
Time frame: Approximately 6 months
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
PK profiles and following parameter, where data allow (ke1)
Time frame: Approximately 6 months
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
PK profiles and following parameter, where data allow (t1/2)
Time frame: Approximately 6 months
To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BL1332 ophthalmic solution in people with Ocular Pain, run by Bausch & Lomb Incorporated at 1 site 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 11 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of DLTs (dose-limiting toxicities) (time frame: Approximately 6 months). The study lists 12 primary outcomes in all. 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 27 Jan 2026.