Back to resultsRTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
Primary Purpose
Inflammation and Pain Following Ocular Surgery
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omaveloxolone Ophthalmic Suspension 1.0%
Omaveloxolone Opthalmic Suspension 0.5%
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation and Pain Following Ocular Surgery focused on measuring RTA 408, Ocular surgery, Cataract surgery, Ocular inflammation, Ocular pain, Eye inflammation, omaveloxolone
Eligibility Criteria
Inclusion Criteria:
- Be greater than or equal to 18 years of age of either sex or any race;
- Have undergone unilateral cataract extraction via phacoemulsification on the day prior to study enrollment/randomization;
- Have a grade of ≥2 in anterior chamber cell score on day after surgery (Day 1);
- Have a potential post-operative pin-hole visual acuity (VA) of greater than 1.0 logarithm of the minimum angle of resolution (logMAR) in the operative eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart;
Exclusion Criteria:
- Have any intraocular inflammation present in the study eye during the screening slit lamp examination;
- Have a score greater than "0" on the Ocular Pain Assessment at Screening in the study eye;
- Have an 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;
- Require the use of a contact lens or a collagen shield within 72 hours of investigational drug treatment or during the study period in the study eye; be unwilling to discontinue use of contact lenses during study period in the study eye;
- Require use of non-diagnostic topical ophthalmic solutions (other than perioperative mydriatics, anesthetics and antiseptics, prophylactic antibiotics, lid scrubs for mild blepharitis, or artificial tears for the management of dry eye) in the study eye for the duration of the study;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Omaveloxolone Ophthalmic Suspension 1.0%
Omaveloxolone Ophthalmic Suspension 0.5%
Placebo
Arm Description
Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery
Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery
Patients will receive a single drop of vehicle for Omaveloxolone Ophthalmic suspension was instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery
Outcomes
Primary Outcome Measures
Absence of Anterior Chamber Cells at Day 15 (Visit 5)
Count of participants who had absence of anterior chamber cells at Day 15. White blood cells were counted. In a healthy eye, the anterior chamber should not have any blood cells present. "Yes" indicates an absence of anterior chamber cells. Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward.
Absence of Ocular Pain at Day 4 (Visit 3)
Participants were asked to report their pain on Day 4 using the Numerical Pain Rating Scale (NPRS) for patients receiving active drug compared to patients receiving placebo. The NPRS is an 11-point numeric scale, which ranges from "0" representing "no pain" to "10" representing the "worst pain imaginable". Lower scores indicate less pain. Participants reporting '0' were recorded as "Yes" while patients reporting any other pain score were recorded as "No". Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward.
Secondary Outcome Measures
Full Information
NCT ID
NCT02065375
First Posted
February 13, 2014
Last Updated
May 30, 2023
Sponsor
Reata Pharmaceuticals, Inc.
Collaborators
AbbVie
1. Study Identification
Unique Protocol Identification Number
NCT02065375
Brief Title
RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
Official Title
A Multicenter, Randomized, Dose-Ranging, Double-Masked, Placebo-Controlled Phase 2 Study Evaluating the Safety and Efficacy of RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (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 RTA 408 Ophthalmic Suspension in the treatment of patients who have inflammation and pain following ocular surgery.
Detailed Description
Following ophthalmic surgery, the current standard of care includes a topical ophthalmic corticosteroid or other anti-inflammatory agent to treat ocular inflammation and improve patient comfort. If left untreated, inflammation of the eye may result in further ocular complications including scarring, vision loss, or blindness. Although the exact dosing regimen is physician-dependent, patients are typically prescribed a topical corticosteroid for a period of 2-4 weeks following surgery, being tapered over the course of delivery as the inflammation subsides. Topical anti-inflammatory agents are usually administered multiple times per day, particularly in the early period following ophthalmic surgery. Continuing efforts in drug development aim to identify alternatives to ophthalmic corticosteroid use, due to their well-known local and systemic negative side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation and Pain Following Ocular Surgery
Keywords
RTA 408, Ocular surgery, Cataract surgery, Ocular inflammation, Ocular pain, Eye inflammation, omaveloxolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omaveloxolone Ophthalmic Suspension 1.0%
Arm Type
Experimental
Arm Description
Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery
Arm Title
Omaveloxolone Ophthalmic Suspension 0.5%
Arm Type
Experimental
Arm Description
Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive a single drop of vehicle for Omaveloxolone Ophthalmic suspension was instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery
Intervention Type
Drug
Intervention Name(s)
Omaveloxolone Ophthalmic Suspension 1.0%
Other Intervention Name(s)
RTA 408
Intervention Type
Drug
Intervention Name(s)
Omaveloxolone Opthalmic Suspension 0.5%
Other Intervention Name(s)
RTA 408
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Absence of Anterior Chamber Cells at Day 15 (Visit 5)
Description
Count of participants who had absence of anterior chamber cells at Day 15. White blood cells were counted. In a healthy eye, the anterior chamber should not have any blood cells present. "Yes" indicates an absence of anterior chamber cells. Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward.
Time Frame
15 days after the participant receives the first dose
Title
Absence of Ocular Pain at Day 4 (Visit 3)
Description
Participants were asked to report their pain on Day 4 using the Numerical Pain Rating Scale (NPRS) for patients receiving active drug compared to patients receiving placebo. The NPRS is an 11-point numeric scale, which ranges from "0" representing "no pain" to "10" representing the "worst pain imaginable". Lower scores indicate less pain. Participants reporting '0' were recorded as "Yes" while patients reporting any other pain score were recorded as "No". Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward.
Time Frame
4 days after the participant receives the first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be greater than or equal to 18 years of age of either sex or any race;
Have undergone unilateral cataract extraction via phacoemulsification on the day prior to study enrollment/randomization;
Have a grade of ≥2 in anterior chamber cell score on day after surgery (Day 1);
Have a potential post-operative pin-hole visual acuity (VA) of greater than 1.0 logarithm of the minimum angle of resolution (logMAR) in the operative eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart;
Exclusion Criteria:
Have any intraocular inflammation present in the study eye during the screening slit lamp examination;
Have a score greater than "0" on the Ocular Pain Assessment at Screening in the study eye;
Have an 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;
Require the use of a contact lens or a collagen shield within 72 hours of investigational drug treatment or during the study period in the study eye; be unwilling to discontinue use of contact lenses during study period in the study eye;
Require use of non-diagnostic topical ophthalmic solutions (other than perioperative mydriatics, anesthetics and antiseptics, prophylactic antibiotics, lid scrubs for mild blepharitis, or artificial tears for the management of dry eye) in the study eye for the duration of the study;
Facility Information:
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
City
Elizabeth City
State/Province
North Carolina
ZIP/Postal Code
27909
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
75022
Country
United States
12. IPD Sharing Statement
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RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
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