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NCT Number: NCT06978244

A Study to Assess Safety, Tolerability, and Pharmacokinetics of Ascending Concentrations of Topical Ocular BL1332 in Healthy Volunteers

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ocular Pain Eye Diseases Eye Manifestations Eye Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site 101

Fair Lawn, New Jersey, 07410, United States

About this 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)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

BL1332 ophthalmic solution

Drug

Both arms taken four times a day for 1 day

BL1332 ophthalmic vehicle

Drug

Both arms taken four times a day for 1 day

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2025
Registry last updated
Jan 27, 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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