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RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery

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ClinicalTrials.gov Identifier: NCT02065375
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : November 6, 2014
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Inflammation and Pain Following Ocular Surgery Drug: RTA 408 0.5% Ophthalmic Suspension Drug: RTA 408 1.0% Ophthalmic Suspension Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: RTA 408 0.5% Ophthalmic Suspension or Placebo
Patients will be randomized to twice-daily dosing of ophthalmic suspension (RTA 408 0.5% or Placebo) in the study eye for 14 days
Drug: RTA 408 0.5% Ophthalmic Suspension
Drug: Placebo
Experimental: RTA 408 1.0% Ophthalmic Suspension or Placebo
Patients will be randomized to twice-daily dosing of ophthalmic suspension (RTA 408 1.0% or Placebo) in the study eye for 14 days
Drug: RTA 408 1.0% Ophthalmic Suspension
Drug: Placebo



Primary Outcome Measures :
  1. Anterior Chamber Cell Count [ Time Frame: 14 days ]
    Count anterior chamber cells


Secondary Outcome Measures :
  1. Pain [ Time Frame: 14 days ]
    Pain score on a visual analog scale



Information from the National Library of Medicine

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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. Be greater than or equal to 18 years of age of either sex or any race;
  2. Have undergone unilateral cataract extraction via phacoemulsification on the day prior to study enrollment/randomization;
  3. Have a grade of ≥2 in anterior chamber cell score on day after surgery (Day 1);
  4. 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:

  1. Have any intraocular inflammation present in the study eye during the screening slit lamp examination;
  2. Have a score greater than "0" on the Ocular Pain Assessment at Screening in the study eye;
  3. Have an immunosuppressive disease or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface;
  4. Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing;
  5. Have an intraocular pressure (IOP) ≤ 5 mmHg in either eye;
  6. 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;
  7. 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;

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): NCT02065375


Locations
United States, California
Garden Grove, California, United States, 92843
United States, Florida
Fort Myers, Florida, United States, 33907
United States, Missouri
Kansas City, Missouri, United States, 64133
United States, North Carolina
Elizabeth City, North Carolina, United States, 27909
United States, Texas
Austin, Texas, United States, 78731
Houston, Texas, United States, 75022
Sponsors and Collaborators
Reata Pharmaceuticals, Inc.
AbbVie

Responsible Party: Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02065375     History of Changes
Other Study ID Numbers: RTA 408-C-1307
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: October 2014

Keywords provided by Reata Pharmaceuticals, Inc.:
RTA 408
Ocular surgery
Cataract surgery
Ocular inflammation
Ocular pain
Eye inflammation

Additional relevant MeSH terms:
Inflammation
Pathologic Processes