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Efficacy and Safety of XG-102 in Reduction of Post-cataract Surgery Intraocular Inflammation and Pain

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: NCT02508337
Recruitment Status : Completed
First Posted : July 24, 2015
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Xigen SA

Tracking Information
First Submitted Date  ICMJE July 20, 2015
First Posted Date  ICMJE July 24, 2015
Last Update Posted Date January 24, 2017
Study Start Date  ICMJE July 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
  • Absence of anterior chamber cells [ Time Frame: Day 15 ]
  • Pain scores as measured by the visual analog scale [ Time Frame: Day2 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
  • Use of rescue medication [ Time Frame: up to D22 ]
  • Number of patients with adverse events [ Time Frame: up to D22 ]
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 Efficacy and Safety of XG-102 in Reduction of Post-cataract Surgery Intraocular Inflammation and Pain
Official Title  ICMJE A Multicenter, Randomized, Double-masked, Vehicle-controlled, Parallel Group Phase III Study of the Efficacy and Safety of a Single Sub-conjunctival Injection of XG-102 for the Reduction of Post-cataract Surgery Intraocular Inflammation
Brief Summary The purpose of this study is to evaluate the clinical efficacy and safety of XG-102 (900µg) compared to vehicle in the treatment of subjects with inflammation and pain following cataract surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Inflammation
  • Pain
  • Cataract
Intervention  ICMJE
  • Drug: XG-102
    Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery
  • Drug: Placebo
    Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery
Study Arms  ICMJE
  • Experimental: XG-102
    sterile ophthalmic solution for sub-conjunctival injection
    Intervention: Drug: XG-102
  • Placebo Comparator: placebo
    sterile ophthalmic solution for sub-conjunctival injection
    Intervention: 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: January 7, 2016)
309
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2015)
300
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have provided written informed consent, approved by the appropriate institutional review board;
  • Be greater than or equal to 18 years of age of either sex or any race;
  • Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye;
  • Have a pin-hole visual acuity (VA) < 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 at Visit 1;
  • (For females of childbearing potential) agree to have urine pregnancy testing performed at Visit 1 (must be negative) and at exit visit; must not be lactating; and must agree to use a medically acceptable form of birth control1 throughout the study duration. Women of childbearing potential include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).

Exclusion Criteria:

  • Have a known sensitivity or allergy to the class of medication of the active ingredient in the study medication or any of the study medication's components;
  • Have any intraocular inflammation (e.g., white blood cells or flare) present in the study eye at the Visit 1slit lamp examination;
  • Have a score greater than "0" on the Ocular Pain Assessment at Visit 1 or 2 in the study eye;
  • Have an immunosuppressive or an autoimmune disease that in the opinion of the Investigator could affect intraocular inflammation or the normal healing process of the eye;
  • Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing;
  • Currently have suspected or known malignancy or be currently receiving antineoplastic therapy;
  • Be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the study duration, or have a positive urine pregnancy test at Visit 1;
  • Use anti-inflammatory agents, analgesics/pain relievers (including opioids, narcotics and other pain medications) or immunomodulating agents, systemically, or in either eye, and/or use medications for benign prostatic hyperplasia (BPH), from the washout period through 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 NCT02508337
Other Study ID Numbers  ICMJE SDD-1002-065
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xigen SA
Study Sponsor  ICMJE Xigen SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Juli Chalifour ORA, Inc.
PRS Account Xigen SA
Verification Date January 2017

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