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

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: 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.

Tracking Information
First Submitted Date  ICMJE February 13, 2014
First Posted Date  ICMJE February 19, 2014
Last Update Posted Date November 6, 2014
Study Start Date  ICMJE February 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
Anterior Chamber Cell Count [ Time Frame: 14 days ]
Count anterior chamber cells
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02065375 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
Pain [ Time Frame: 14 days ]
Pain score on a visual analog scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Inflammation and Pain Following Ocular Surgery
Intervention  ICMJE
  • Drug: RTA 408 0.5% Ophthalmic Suspension
  • Drug: RTA 408 1.0% Ophthalmic Suspension
  • Drug: Placebo
Study Arms  ICMJE
  • 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
    Interventions:
    • 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
    Interventions:
    • Drug: RTA 408 1.0% Ophthalmic Suspension
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2014)
109
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2014)
105
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02065375
Other Study ID Numbers  ICMJE RTA 408-C-1307
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Reata Pharmaceuticals, Inc.
Study Sponsor  ICMJE Reata Pharmaceuticals, Inc.
Collaborators  ICMJE AbbVie
Investigators  ICMJE Not Provided
PRS Account Reata Pharmaceuticals, Inc.
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP