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

NCT04981886 | Unknown Phase 4 FDA Drug

• 1 other identifier: HMS1311
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Normal Tension Glaucoma

Keywords

Glaucoma; Normal tension glaucoma; Intraocular pressure; Central corneal thickness; Corneal hysteresis; Prostaglandin analog; Prostamide

Outcome Measures

Primary Outcomes (1)

• Post-treatment IOP

  Change in IOPs (GAT, DCT, and ORA) from baseline.

  3 months post-treatment

Secondary Outcomes (4)

• Post-treatment IOP change by CCT

  3 months post-treatment

• Post-treatment IOP change by CH

  3 months post-treatment

• Post-treatment change in CCT

  3 months post-treatment

• Post-treatment change in CH

  3 months post-treatment

Study Arms (2)

Group 1: Normal tension glaucoma subjects with thin corneas

EXPERIMENTAL

NTG subjects with CCT ≤ 540 nm will be randomized to receive either netarsudil or bimatoprost.

Drug: Netarsudil Ophthalmic; Drug: Bimatoprost Ophthalmic

Group 2: Normal tension glaucoma subjects with thick corneas

EXPERIMENTAL

NTG subjects with CCT \> 540 nm will be randomized to receive either netarsudil or bimatoprost.

Drug: Netarsudil Ophthalmic; Drug: Bimatoprost Ophthalmic

Interventions

Netarsudil Ophthalmic DRUG

Subjects will be randomly assigned to this group

Also known as: Rhopressa

Group 1: Normal tension glaucoma subjects with thin corneas; Group 2: Normal tension glaucoma subjects with thick corneas

Bimatoprost Ophthalmic DRUG

Subjects will be randomly assigned to this group

Also known as: Lumigan

Group 1: Normal tension glaucoma subjects with thin corneas; Group 2: Normal tension glaucoma subjects with thick corneas

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients with IOPs greater than 21 mmHg at any previous point in time
• Patients with corneal pathology
• Previous ocular surgery in the past 6 months
• Patients with any other types of glaucoma other than NTG
• Patients who are unwilling or unable to follow-up for a 3-month period
• Patients with systemic conditions where a non-glaucomatous optic neuropathy cannot be ruled out.
• Subjects who are pregnant, breastfeeding, or considering becoming pregnant
• Subjects who could be pregnant will be screened for pregnancy thus: Those who are not pregnant nor considering becoming pregnant and are not on any birth-control at the time of recruitment will be excluded from participation because of the risk of pregnancy unknown to the patient at the time of recruitment.

Sponsors & Collaborators

• Salus University: lead

Study Sites (1)

Roberts Eyecare Associates

Vestal, New York, 13850, United States

Location

MeSH Terms

Conditions

Low Tension Glaucoma; Glaucoma

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Jingyun Wang, Ph.D

  Salus University

  STUDY DIRECTOR

Central Study Contacts

Edgar U Ekure, OD, MS

CONTACT

3157532421; exe0003@salus.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 29, 2021
• Study Start: August 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 6 months to 1 year after after completion of study
• Access Criteria: Access to IPD shall be obtained through email request from Edgar U Ekure (OD, MS, FAAO). Email: exe0003@salus.edu

Locations

US (1)