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RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD

Primary Purpose

Corneal Endothelial Cell Loss, Ocular Pain, Ocular Inflammation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vehicle Ophthalmic Solution
Omaveloxolone Ophthalmic Suspension 0.5%
Omaveloxolone Ophthalmic Suspension 1%
Sponsored by
Reata Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Corneal Endothelial Cell Loss focused on measuring RTA 408, Cataract surgery, Corneal Endothelial Cells, omaveloxolone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be male or female and ≥18 years of age and ≤80 years of age
  2. Plan to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens
  3. Have the potential, in the opinion of the investigator, to improve best-corrected visual acuity in the study eye after surgery
  4. Have Grade 3, 4, or 5 nuclear cataract in the study eye, according to the LOCS III
  5. Have corneal endothelium in the study eye that can be accurately assessed using specular microscopy
  6. Have endothelial cell density of >1800 cells/mm2 in the study eye at the Screening Visit
  7. Have a pinhole visual acuity (VA) of at least 1.0 logarithm of the minimum angle of resolution (logMAR) in the study eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart

Exclusion Criteria:

  1. Have a score >0 on the ocular pain assessment at the Screening Visit or the Randomization Visit in the study eye
  2. Have an active immunosuppressive disease or an autoimmune disease that, in the opinion of the investigator, could affect the quality of the ocular surface
  3. Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing
  4. Have an intraocular pressure (IOP) ≤5 mmHg in either eye
  5. Have had corneal or retinal surgery (laser or incisional) within the past 6 months, or be planning to have laser or incisional surgery during the study period in the study eye
  6. Have the presence of guttae Stage 2 or greater or other abnormality in the study eye that does not allow for accurate corneal endothelial cell assessments

Sites / Locations

  • Harvard Eye Associates
  • Hull Eye Center
  • Argus Research
  • Levenson Eye Associates
  • Chicago Cornea Consultants
  • JacksonEye
  • Discover Vision Centers
  • Opthalmic Consultants of Boston
  • Talamo Hatch Laser Eye Consultants
  • Associated Eye Care
  • Comprehensive Eye Care
  • Alterman, Modi and Wolter
  • Cincinnati Eye Institute
  • R & R Eye Research
  • See Clearly Vision Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Vehicle Ophthalmic Solution

Omaveloxolone Opthalmic Suspension 0.5%

Omaveloxolone Opthalmic Suspension 1%

Arm Description

A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery

A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery

A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery

Outcomes

Primary Outcome Measures

Change From Baseline in Central Corneal Endothelial Cell Counts
Count of central corneal endothelial cells 12 weeks post cataract surgery, compared to baseline

Secondary Outcome Measures

Percentage of Patients With Absence of Anterior Chamber Cells at 2 Weeks After Cataract Surgery
Absence of of anterior chamber cells is defined as anterior chamber cells = 0
Percentage of Patients With Absence of Anterior Chamber Flare at 2 Weeks After Cataract Surgery
Absence of of anterior chamber flare is defined as anterior chamber flare = 0
Percentage of Patients With Clinical Cure (Absence of Anterior Chamber Cells + Flare) at 2 Weeks After Cataract Surgery
Absence of of anterior chamber cells + flare is defined as anterior chamber cells + flare = 0
Percentage of Patients Who Were Pain Free 1 Day After Cataract Surgery
Change From Baseline in Central Corneal Endothelial Cell Counts
Count of central corneal endothelial cells 6 weeks post cataract surgery, compared to baseline

Full Information

First Posted
April 28, 2014
Last Updated
May 24, 2023
Sponsor
Reata Pharmaceuticals, Inc.
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02128113
Brief Title
RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD
Official Title
A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Phase 2 Study of the Efficacy and Safety of RTA 408 For the Prevention of Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reata Pharmaceuticals, Inc.
Collaborators
AbbVie

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.
Detailed Description
Many ocular diseases are characterized by oxidative stress and/or inflammation. Oxidative stress is also known to adversely impact corneal endothelial cells, and may be a factor resulting in the acute decrease in corneal endothelial cell density following ocular surgery. While corticosteroids provide potent anti-inflammatory efficacy in a wide range of acute and chronic inflammatory ocular diseases, their use is limited by their side effect profile, which includes the potential to elevate IOP and induce cataract formation. In addition, most available ophthalmic anti-inflammatory treatments, including corticosteroids, do not directly protect against the underlying oxidative stress component of the disease process. Consequently, there is a clinical need for agents that protect against oxidative stress and provide anti-inflammatory efficacy without inducing steroid-like side effects. This study will assess the safety and efficacy of omaveloxolone (RTA 408) Ophthalmic Suspension (0.5% or 1%) versus vehicle for the prevention of corneal endothelial cell loss in patients undergoing cataract surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Endothelial Cell Loss, Ocular Pain, Ocular Inflammation, Cataract Surgery
Keywords
RTA 408, Cataract surgery, Corneal Endothelial Cells, omaveloxolone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vehicle Ophthalmic Solution
Arm Type
Placebo Comparator
Arm Description
A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Arm Title
Omaveloxolone Opthalmic Suspension 0.5%
Arm Type
Experimental
Arm Description
A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Arm Title
Omaveloxolone Opthalmic Suspension 1%
Arm Type
Experimental
Arm Description
A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Intervention Type
Drug
Intervention Name(s)
Vehicle Ophthalmic Solution
Intervention Description
Opthalmic suspension manufactured to mimic RTA 408 suspension
Intervention Type
Drug
Intervention Name(s)
Omaveloxolone Ophthalmic Suspension 0.5%
Other Intervention Name(s)
RTA 408 Ophthalmic Suspension 0.5%
Intervention Description
0.5% ophthalmic suspension of RTA 408
Intervention Type
Drug
Intervention Name(s)
Omaveloxolone Ophthalmic Suspension 1%
Other Intervention Name(s)
RTA 408 Ophthalmic Suspension 1%
Intervention Description
1% ophthalmic suspension of RTA 408
Primary Outcome Measure Information:
Title
Change From Baseline in Central Corneal Endothelial Cell Counts
Description
Count of central corneal endothelial cells 12 weeks post cataract surgery, compared to baseline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Patients With Absence of Anterior Chamber Cells at 2 Weeks After Cataract Surgery
Description
Absence of of anterior chamber cells is defined as anterior chamber cells = 0
Time Frame
2 weeks
Title
Percentage of Patients With Absence of Anterior Chamber Flare at 2 Weeks After Cataract Surgery
Description
Absence of of anterior chamber flare is defined as anterior chamber flare = 0
Time Frame
2 weeks
Title
Percentage of Patients With Clinical Cure (Absence of Anterior Chamber Cells + Flare) at 2 Weeks After Cataract Surgery
Description
Absence of of anterior chamber cells + flare is defined as anterior chamber cells + flare = 0
Time Frame
2 weeks
Title
Percentage of Patients Who Were Pain Free 1 Day After Cataract Surgery
Time Frame
1 day
Title
Change From Baseline in Central Corneal Endothelial Cell Counts
Description
Count of central corneal endothelial cells 6 weeks post cataract surgery, compared to baseline
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be male or female and ≥18 years of age and ≤80 years of age Plan to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens Have the potential, in the opinion of the investigator, to improve best-corrected visual acuity in the study eye after surgery Have Grade 3, 4, or 5 nuclear cataract in the study eye, according to the LOCS III Have corneal endothelium in the study eye that can be accurately assessed using specular microscopy Have endothelial cell density of >1800 cells/mm2 in the study eye at the Screening Visit Have a pinhole visual acuity (VA) of at least 1.0 logarithm of the minimum angle of resolution (logMAR) in the study eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart Exclusion Criteria: Have a score >0 on the ocular pain assessment at the Screening Visit or the Randomization Visit in the study eye Have an active immunosuppressive disease or an autoimmune disease that, in the opinion of the investigator, could affect the quality of the ocular surface Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing Have an intraocular pressure (IOP) ≤5 mmHg in either eye Have had corneal or retinal surgery (laser or incisional) within the past 6 months, or be planning to have laser or incisional surgery during the study period in the study eye Have the presence of guttae Stage 2 or greater or other abnormality in the study eye that does not allow for accurate corneal endothelial cell assessments
Facility Information:
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Hull Eye Center
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Argus Research
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33904
Country
United States
Facility Name
Levenson Eye Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Chicago Cornea Consultants
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
JacksonEye
City
Lake Villa
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Facility Name
Discover Vision Centers
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Opthalmic Consultants of Boston
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Talamo Hatch Laser Eye Consultants
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Associated Eye Care
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Comprehensive Eye Care
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Alterman, Modi and Wolter
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
R & R Eye Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
See Clearly Vision Group
City
McLean
State/Province
Virginia
ZIP/Postal Code
22102
Country
United States

12. IPD Sharing Statement

Learn more about this trial

RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD

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