Healthy
Conditions
Brief summary
Single center, double-masked study of BL1332 on Capsaicin-Induced Ocular Pain in Healthy Subjects
Interventions
DRUGBL1332 eye drops
Taken 1 time
DRUGBL1332 Placebo eye drops
Taken 1 time
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular pain severity assessed by numeric pain rating scale (NPRS) | Assessed 5 seconds post-capsaicin dose | NPRS scale 0 to 10, with higher score reflecting worse pain |
Countries
United States
Outcome results
None listed