NCT04498169

Brief Summary

Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 17, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 1, 2022

Completed
Last Updated

September 15, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

July 31, 2020

Results QC Date

August 10, 2022

Last Update Submit

August 31, 2022

Conditions

Corneal Edema

Keywords

Corneal EdemaFuchs Corneal DystrophyNetarsudil Ophthalmic Solution

Outcome Measures

Primary Outcomes (1)

  • Central Corneal Thickness (CCT)

    Mean change from baseline in CCT by ultrasound pachymetry

    Baseline & 4 weeks

Study Arms (2)

Once Daily Netarsudil Ophthalmic Solution

EXPERIMENTAL

One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.

Drug: Netarsudil Ophthalmic

Twice Daily Netarsudil Ophthalmic Solution

EXPERIMENTAL

One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.

Drug: Netarsudil Ophthalmic

Interventions

Netarsudil OphthalmicDRUG

Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution

Also known as: Rhopressa®
Once Daily Netarsudil Ophthalmic Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older
  • Documented diagnosis of FCD
  • Evidence of central corneal edema, in at least one eye, at the Screening and Baseline Visit, in the eligible eye(s)
  • Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the eligible eye(s)

You may not qualify if:

  • FCD so advanced that, in the opinion of the Investigator, surgery would likely be required in the study eligible eye(s) within the study period
  • Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation
  • History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Orange County Ophthalmology

Garden Grove, California, 92843, United States

Location

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

Advance Eye Associates

South Dartmouth, Massachusetts, 02748, United States

Location

Chu Vision Institute

Bloomington, Minnesota, 55420, United States

Location

Minnesota Eye Care

Minnetonka, Minnesota, 55305, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Vance Thompson Vision

West Fargo, North Dakota, 58078, United States

Location

Comprehensive Eye Care

Westerville, Ohio, 43082, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

Related Publications (1)

  • Lindstrom RL, Lewis AE, Holland EJ, Sheppard JD, Hovanesian JA, Senchyna M, Hollander DA. Phase 2, Randomized, Open-Label Parallel-Group Study of Two Dosing Regimens of Netarsudil for the Treatment of Corneal Edema Due to Fuchs Corneal Dystrophy. J Ocul Pharmacol Ther. 2022 Dec;38(10):657-663. doi: 10.1089/jop.2022.0069. Epub 2022 Nov 3.

    PMID: 36327101DERIVED

MeSH Terms

Conditions

Corneal EdemaFuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesCorneal Dystrophies, HereditaryEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Michelle Senchyna, PhD. VP, Clinical Development and Medical Affairs.
Organization
Aerie Pharmaceuticals Inc.
msenchyna@aeriepharma.com
+1 908-947-3551

Study Officials

  • Michelle Senchyna, Ph.D.

    Aerie Pharmaceuticals Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 4, 2020

Study Start

September 17, 2020

Primary Completion

August 11, 2021

Study Completion

August 11, 2021

Last Updated

September 15, 2022

Results First Posted

September 1, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(12)