NCT07717918

Brief Summary

Single center, double-masked study of BL1332 on Capsaicin-Induced Ocular Pain in Healthy Subjects

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2026

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

26 days

First QC Date

July 16, 2026

Last Update Submit

July 16, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Ocular pain severity assessed by numeric pain rating scale (NPRS)

    NPRS scale 0 to 10, with higher score reflecting worse pain

    Assessed 5 seconds post-capsaicin dose

Study Arms (2)

BL1332 eye drops

ACTIVE COMPARATOR
Drug: BL1332 eye drops

BL1332 Placebo eye drops

PLACEBO COMPARATOR
Drug: BL1332 Placebo eye drops

Interventions

BL1332 eye dropsDRUG

Taken 1 time

BL1332 eye drops
BL1332 Placebo eye dropsDRUG

Taken 1 time

BL1332 Placebo eye drops

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female ≥ 18 to ≤ 65 years of age.
  • In good health, as assessed at Screening by the Investigator from past medical history, physical examination (abbreviated), and laboratory tests.
  • Does not wear contact lenses, or is willing to refrain from wearing contact lenses for the duration of the study.

You may not qualify if:

  • 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.
  • Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of IP, safe participation in this study, or confound the assessment of safety or efficacy.
  • Unwilling or unable to comply with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 101

Newport Beach, California, 92663, United States

RECRUITING

Central Study Contacts

Celia Busby

CONTACT

9453277624celia.busby@bausch.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 21, 2026

Study Start

July 6, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

July 21, 2026

Record last verified: 2026-07

Locations

US(1)