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Trial record 3 of 33 for:    Aerie

A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy (Fuchs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04498169
Recruitment Status : Completed
First Posted : August 4, 2020
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Corneal Edema Drug: Netarsudil Ophthalmic Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Dosing Regimens of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
Actual Study Start Date : September 17, 2020
Actual Primary Completion Date : August 11, 2021
Actual Study Completion Date : August 11, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Once Daily Netarsudil Ophthalmic Solution
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
Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
Other Name: Rhopressa®

Experimental: Twice Daily Netarsudil Ophthalmic Solution
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
Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
Other Name: Rhopressa®




Primary Outcome Measures :
  1. Central Corneal Thickness (CCT) [ Time Frame: 28 Days ]
    Mean change from baseline in CCT by ultrasound pachymetry



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation
  3. History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04498169


Locations
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United States, California
Principal Investigator
Garden Grove, California, United States, 92843
Principal Investigator
Laguna Hills, California, United States, 92653
United States, Illinois
Principal Investigator
Hoffman Estates, Illinois, United States, 60169
United States, Kentucky
Principal Investigator
Edgewood, Kentucky, United States, 41017
United States, Massachusetts
Principal Investigator
Boston, Massachusetts, United States, 02114
Principal Investigator
South Dartmouth, Massachusetts, United States, 02748
United States, Minnesota
Principal Investigator
Bloomington, Minnesota, United States, 55420
Principal Investigator
Minnetonka, Minnesota, United States, 55305
United States, Missouri
Principal Investigator
Kansas City, Missouri, United States, 64133
Principal Investigator
Saint Louis, Missouri, United States, 63131
United States, North Dakota
Principal Investigator
W. Fargo, North Dakota, United States, 58078
United States, Ohio
Principal Investigator
Westerville, Ohio, United States, 43082
United States, South Dakota
Principal Investigator
Sioux Falls, South Dakota, United States, 57108
United States, Texas
Principal Investigator
Houston, Texas, United States, 77025
United States, Virginia
Principal Investigator
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
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Study Director: Michelle Senchyna, Ph.D. Aerie Pharmaceuticals Inc.
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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04498169    
Other Study ID Numbers: AR-13324-CS210
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aerie Pharmaceuticals:
Corneal Edema
Fuchs Corneal Dystrophy
Netarsudil Ophthalmic Solution
Additional relevant MeSH terms:
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Corneal Dystrophies, Hereditary
Corneal Edema
Fuchs' Endothelial Dystrophy
Edema
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn