Primary Open Angle Glaucoma or Ocular Hypertension
Conditions
Keywords
primary open angle glaucoma, ocular hypertension, SLT, POAG, Selective Laser Trabeculoplasty, Rhopressa, netarsudil
Brief summary
The purpose of this study is to collect data about how Rhopressa affects IOP in patients who have had an SLT procedure in both eyes.
Detailed description
This is a prospective, randomized, double-masked, placebo controlled (artificial tears), single center study. The study population will include seventy (n=70) subjects with POAG or ocular hypertension who have undergone SLT and may benefit from additional IOP reduction. If individuals are a candidate for treatment with Rhopressa (netarsudil) 0.02% ophthalmic solution post-SLT, they can potentially be included in the trial. The study duration per subject is expected to be 6 weeks (or up to 12 weeks if washout is required for previous IOP lowering treatment) with three scheduled study visits. While both Rhopressa and 360 degrees SLT primarily target the trabecular meshwork, potential synergistic effects of the two therapies on conventional aqueous outflow are not completely understood. This study will determine whether initiation of Rhopressa post-360 degrees SLT provides greater IOP reduction than 360 degrees SLT alone. This information will aid healthcare providers in selecting the best approach to management of IOP in patients who have recently undergone 360 degrees SLT and may benefit from additional IOP reduction.
Interventions
Apply one drop in each eye every evening
DRUGArtificial tears
Apply one drop in each eye every evening
Sponsors
East Coast Institute for Research
Alcon, a Novartis Company
Florida Eye Specialists
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Documented diagnosis of bilateral POAG or ocular hypertension as determined by the investigator based on medical record review. 3. At Screening (V1), the subject completed SLT in both the eyes within the last 90 days. 4. Mean diurnal IOP of 16 to 28 mmHg at Randomization (V2 ) 5. At Randomization (V2), in the opinion of the investigator, subject may benefit from additional IOP reduction in the study eye and is a candidate for treatment with Rhopressa 6. At Randomization (V2), if treated with IOP-lowering medication(s) in either eye prior to SLT, subject has completed the minimum washout period for the medication(s) (see Table 1) 7. If female, subject is either incapable of pregnancy (e.g., history of bilateral oophorectomy, hysterectomy, bilateral tubal ligation) or post-menopausal (amenorrheic for at least 2 years) or will use an effective (e.g., double barrier) method of birth control for the duration of the study
Exclusion criteria
1. History of more than one treatment with SLT in either eye 2. Unable or unwilling to discontinue current IOP-lowering medication(s), if applicable 3. Prior or current treatment with a rho kinase inhibitor 4. Prior microinvasive glaucoma surgery (MIGS) 5. Advanced stage of glaucoma, as determined by the investigator based on medical record review 6. Any condition that prevents reliable applanation tonometry in either eye (e.g., significant corneal surface abnormalities, scars, keratoconus) 7. Previous or currently active corneal disease that, in the opinion of the investigator, could affect the study outcomes 8. Active or recurrent intraocular infection, inflammation, iritis or uveitis 9. Retinal disease (e.g., diabetic retinopathy, macular degeneration, central retinal vein or artery occlusion, macular edema) 10. Intraocular injection performed ≤ 6 months prior to Screening (V1) 11. Anticipated use of any topical ocular steroids and/or topical ocular nonsteroidal anti-inflammatory drugs (NSAID) during the study period 12. Current participation in any drug or device clinical investigation, receipt of investigational drug within 6 drug half-lives of Screening (V1), or any previous placement of an investigational device. 13. Any condition in the opinion of the investigator that would potentially confound the results of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean diurnal intraocular pressure (IOP) | 42 Days | Between-group difference in change in mean diurnal IOP |
Countries
United States
Outcome results
None listed