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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02508337
First Posted: July 24, 2015
Last Update Posted: January 24, 2017
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.
Information provided by (Responsible Party):
Xigen SA
  Purpose
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.

Condition Intervention Phase
Inflammation Pain Cataract Drug: XG-102 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Xigen SA:

Primary Outcome Measures:
  • Absence of anterior chamber cells [ Time Frame: Day 15 ]
  • Pain scores as measured by the visual analog scale [ Time Frame: Day2 ]

Secondary Outcome Measures:
  • Use of rescue medication [ Time Frame: up to D22 ]
  • Number of patients with adverse events [ Time Frame: up to D22 ]

Enrollment: 309
Study Start Date: July 2015
Study Completion Date: March 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XG-102
sterile ophthalmic solution for sub-conjunctival injection
Drug: XG-102
Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery
Placebo Comparator: placebo
sterile ophthalmic solution for sub-conjunctival injection
Drug: Placebo
Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT02508337


Locations
United States, Massachusetts
Ora
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Xigen SA
Investigators
Study Director: Juli Chalifour ORA, Inc.
  More Information

Responsible Party: Xigen SA
ClinicalTrials.gov Identifier: NCT02508337     History of Changes
Other Study ID Numbers: SDD-1002-065
First Submitted: July 20, 2015
First Posted: July 24, 2015
Last Update Posted: January 24, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Inflammation
Cataract
Uveitis
Pathologic Processes
Lens Diseases
Eye Diseases
Uveal Diseases
Ophthalmic Solutions
Pharmaceutical Solutions