Intraocular Pressure Reduction Efficacy of Rhopressa and Lumigan in Normal Tension Glaucoma (NCT04981886) | Clinical Trial Compass
UnknownPhase 4
Intraocular Pressure Reduction Efficacy of Rhopressa and Lumigan in Normal Tension Glaucoma
United States115 participantsStarted 2021-08
Plain-language summary
Glaucoma is the second leading cause of blindness and the first leading cause of irreversible vision loss worldwide. The intraocular pressure (IOP) is the only modifiable risk factor for all the spectrum of glaucoma. Reducing IOP in glaucoma increases the likelihood of preventing progression of the disease and preserving the quality of life of the patient. Although prostaglandin analogs (PGAs) and prostamides (PMs) are de facto first-line treatment options for managing glaucoma, it is a common clinical experience to see their treatment effects plateau to a level beyond which no clinically significant IOP reduction is likely. It is also common to find minimal IOP treatment effects in the following conditions: patients with normal tension glaucoma (NTG), patients with thicker central corneal thickness (CCT), and patients with higher levels of corneal hysteresis (CH). CH is a possible proxy for the ability of the scleral tissue around the optic nerve to dissipate energy away from the optic nerve fibers. Netarsudil, a rho-kinase inhibitor was recently approved by the FDA for the treatment of glaucoma and ocular hypertension. There is a paucity of research on the efficacy of netarsudil in patients with NTG, thicker CCT, and higher levels of CH. This study aims to investigate the above issues by evaluating the efficacy of netarsudil and bimatoprost in subjects with NTG, thicker corneas, and higher levels of CH.
Hypotheses
* Netarsudil will have non-inferior efficacy compared to Bimatoprost in treating NTG.
* Corneal thickness and corneal hysteresis will reduce the efficacy of netarsudil similar to bimatoprost in NTG.
* Netarsudil will change corneal thickness and corneal hysteresis similar to bimatoprost in NTG.
Who can participate
Age range
21 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
-Inclusion Criteria:
* New NTG patients naïve to treatment.
* Patient with 360 degrees open angles on gonioscopy.
* Patients with glaucomatous optic neuropathies (GON).
* Patients with three repeatable visual field defects over two visits.
* Subjects must have IOPs ≤ 21 mmHg and no recorded IOPs \> 21 mmHg at any time.
Glaucomatous optic neuropathy and visual field criteria:
Category 1 and 2 of the glaucoma diagnostic criteria of the International Society of Geographical and Epidemiological Ophthalmology (ISGEO) will be adopted in this study.
ISGEO Category 1 classification of glaucoma:
Reliable and repeatable visual field defects consistent with a glaucomatous optic neuropathy, and either a vertical cup-disc ratio (VCDR) at the 97.5th percentile of the normal population (about 0.7 VCDR), or VCDR asymmetry between the right and left eyes at the 97.5th percentile of the normal population (i.e., about 0.2).
ISGEO Category 2 classification of glaucoma:
Visual field results are not definitive or are unattainable due to patient inability to perform an adequate quality test, and optic disc has VCDR of at the 99.5th percentile of the normal population (i.e., VCDR of about 0.9) or VCDR asymmetry between the right and left eyes at the 99.5th percentile of the normal population (i.e a CDR asymmetry of about 0.3).
-Exclusion Criteria
* Patients with IOPs greater than 21 mmHg at any previous point in time
* Patients with corneal pathology
* Previous ocular surgery in the past 6 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.