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

NCT06978244 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-27

No results posted yet for this study

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)

Conditions

  • Ocular Pain

Interventions

DRUG

BL1332 ophthalmic solution

Both arms taken four times a day for 1 day

DRUG

BL1332 ophthalmic vehicle

Both arms taken four times a day for 1 day

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-29
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06978244 on ClinicalTrials.gov