Intraocular Pressure Reduction Efficacy of Rhopressa and Lumigan in Normal Tension Glaucoma

Conditions

• Normal Tension Glaucoma

Eligibility Criteria

Sex

ALL

Age

21 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• Netarsudil Ophthalmic — DRUG
  Subjects will be randomly assigned to this group
• Bimatoprost Ophthalmic — DRUG
  Subjects will be randomly assigned to this group

Study Details

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.

Key Dates

Start date

Aug 31, 2021

Status verified

Aug 2021

Primary completion

Jul 31, 2022

Completion

Aug 31, 2022

Study Design

Enrollment

115 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1: Normal tension glaucoma subjects with thin corneas
  NTG subjects with CCT ≤ 540 nm will be randomized to receive either netarsudil or bimatoprost.
• Experimental: Group 2: Normal tension glaucoma subjects with thick corneas
  NTG subjects with CCT \> 540 nm will be randomized to receive either netarsudil or bimatoprost.

Primary Outcome Measure

Post-treatment IOP [ Time Frame: 3 months post-treatment ]

Central Contacts

• Edgar U Ekure, OD, MS
  3157532421
  [email protected]

Locations (1)

Find similar trials in Vestal, NY

Related Studies

• Obstructive Sleep Apnea as a Risk Factor for Normal Tension Glaucoma and a Crucial Step in Preventing Blindness
  Not Yet Recruiting · Northwell Health · New York, New York