Ocular Hypertension
Conditions
Keywords
Eye Diseases
Brief summary
The primary objective of this study is to determine the effect of latanoprostene bunod (LBN) ophthalmic solution 0.024% (a single dose and 7 days of once daily \[QD\] dosing) on 2 aspects of aqueous humor (AqH) dynamics (episcleral venous pressure \[EVP\] and outflow facility) in participants with ocular hypertension (OHT).
Detailed description
All participants will receive both the investigational (LBN ophthalmic solution 0.024%) and placebo treatments, with 1 eye receiving LBN 0.024% and the contralateral eye receiving placebo. Each participant will be randomized as to which eye (right or left) will receive LBN 0.024% versus placebo. All participants will undergo a minimum 14-day to maximum 42-day washout period prior to the start of study drug administration.
Interventions
Ophthalmic solution
DRUGPlacebo
Ophthalmic solution, no active ingredient.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
All participants will receive both the investigational and placebo treatments, with 1 eye receiving LBN 0.024% and the contralateral eye receiving placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria * Participants must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved informed consent form (ICF) and are able and willing to comply with all treatment and follow-up/study procedures. * Females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must agree to use an acceptable method of contraception throughout their participation in the study. Ocular Inclusion Criteria * Participants must have a diagnosis of OHT in both eyes (intraocular pressure \[IOP\] ≥22 mmHg prior to starting treatment with IOP-lowering medication) without evidence of glaucomatous optic neuropathy or visual field loss and must also have been receiving IOP-lowering medication for ≥3 months prior to Screening (Visit 1). * Participants must undergo a washout of any existing ocular hypotensive medications in order to determine eligibility. Washout period will vary with the class of medication used (2-6 weeks). * Participants must meet the following IOP requirements at Visit 3 (Eligibility Visit at End of Washout): 1. Intraocular pressure ≥22 mmHg and ≤32 mmHg in both eyes. 2. An increase in IOP of 20% over the Screening (Visit 1) IOP. 3. The difference in IOP between eyes ≤4 mmHg. * Participants must have a best corrected visual acuity (BCV A) in each eye of 20/50 (logarithm of the minimum angle of resolution \[logMAR\] +0.4) or better.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Episcleral Venous Pressure (EVP) at Intervals on Days 1 and 8 | Baseline, 1, 3, and 5 hours post-instillation at Day 1 and 12, 16, and 20 hours post-instillation at Day 8 | EVP will be measured non-invasively by using a custom-designed slit-lamp mounted venomanometer. This device utilizes the pressure chamber technique, in which a clear flexible balloon is placed against the surface of the eye, and the pressure is increased until an episcleral vein is noted to blanche. Each EVP measurement will be determined from the mean of up to 3 readings. EVP (millimeters of mercury \[mmHg\]) will be assessed at 1, 3, and 5 hours post instillation for changes from baseline following a single dose of drug on the first day of treatment and at approximately 12, 16 and 20 hours post-instillation after 7 days of QD in the evening treatment. |
| Change From Baseline in Diurnal (Daytime) EVP at Days 1 and 8 | Baseline, Day 1, Day 8 | EVP will be measured non-invasively by using a custom-designed slit-lamp mounted venomanometer. This device utilizes the pressure chamber technique, in which a clear flexible balloon is placed against the surface of the eye, and the pressure is increased until an episcleral vein is noted to blanche. Each EVP measurement will be determined from the mean of up to 3 readings. Diurnal EVP will be computed for Days 1 and 8 separately as the mean of the posttreatment values observed on the day for each eye. Change from the mean of 2 sets of baseline measurements will be computed for each post-treatment time (including diurnal means) as the post-treatment value minus the baseline value for each eye. The difference between treatments (LBN minus placebo) in change from baseline will be computed for each participant. |
| Change From Baseline in Trabecular Outflow Facility at Intervals on Days 1 and 8 | Baseline, 1, 3, and 5 hours post-instillation at Day 1 and 12, 16, and 20 hours post-instillation at Day 8 | Outflow facility will be measured non-invasively by using constant weight tonography. Four-minute tracings with a 5.5-gram or 7.5-gram weight or two-minute tracings with a 10-gram weight will be used, and tonographic outflow facility will be calculated from the pressure decay curves and standard tables. Outflow facility (mmHg) will be assessed at 1, 3, and 5 hours post instillation for changes from baseline following a single dose of drug on the first day of treatment and at approximately 12, 16 and 20 hours post-instillation after 7 days of QD in the evening treatment. |
| Change From Baseline in Diurnal (Daytime) Trabecular Outflow Facility at Days 1 and 8 | Baseline, Day 1, Day 8 | Outflow facility will be measured non-invasively by using constant weight tonography. Four-minute tracings with a 5.5-gram or 7.5-gram weight or 2-minute tracings with a 10-gram weight will be used, and tonographic outflow facility will be calculated from the pressure decay curves and standard tables. Diurnal trabecular outflow facility will be computed for Days 1 and 8 separately as the mean of the posttreatment values observed on the day for each eye. Change from the mean of 2 sets of baseline measurements will be computed for each post-treatment time (including diurnal means) as the post-treatment value minus the baseline value for each eye. The difference between treatments (LBN minus placebo) in change from baseline will be computed for each participant. |
Countries
United States
Outcome results
None listed