New eye drops for pain enter early safety testing
NCT ID NCT06978244
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests the safety of BL1332 eye drops in 24 healthy adults aged 18 to 50. Researchers will give different strengths of the drops to find the highest dose that people can tolerate without serious side effects. The goal is to see if the drops are safe enough for future studies in people with eye pain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
24 people
The number who actually took part.
- Started
-
Jul 2025
- Expected to finish
-
Nov 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written informed consent prior to conduct of any study-related assessment 2. 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 3. 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 4. Body weight ≥50 kg 5. Body mass index (BMI) between 18.0 and 30.0 kg/m2 \[BMI = Body weight (kg) / Height (m)2\] 6. Corrected visual acuity of 20/40 (Snellen) or better in each eye at Screening 7. Able to communicate well with the Investigator and to understand and comply with the requirements of the study Exclusion Criteria: 1. 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. 1. 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. 2. 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 3. Women who are pregnant, lactating, or breastfeeding are excluded. 2. 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 3. Use of gabapentinoids or opioids within 30 days prior to Screening 4. Use of topical capsaicin within 30 days prior to Screening 5. 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 6. 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 7. 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 8. 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 9. 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 10. Use of cytochrome P450 3A4 (CYP3A4) or CYP3A5 inhibitors or inducers within 2 weeks prior to the Baseline Visit 11. History of any ocular surgery or ocular laser intervention within 6 months prior to Screening 12. 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. 13. Any currently active ocular condition that requires use of topical eye drops 14. Contact lens use within 2 weeks prior to Screening and throughout the study 15. Consumption of alcohol within 48 hours prior to the Baseline Visit and throughout the study 16. Donation or loss of ≥450 mL of blood within 8 weeks prior to Screening or longer, if required by local regulation 17. Hemoglobin \<11.0 g/dL at Screening 18. Current or past history of human immunodeficiency virus (HIV) disease and/or hepatitis 19. Past participation in a clinical study within 30 days prior to Screening
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Ocular pain are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Site 101
Fair Lawn, New Jersey, 07410, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.