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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Inflammation; Cataract
• Intervention / Treatment: Drug: XG-102; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 339
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Garden Grove, California, United States, 92843

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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).

Key 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; comparison of XG-102 versus placebo sub-conjunctival injection efficacy
Experimental: XG-102	Drug: XG-102; Comparison of XG-102 versus placebo sub-conjunctival injection efficacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absence of anterior chamber cells for the 900µg XG-102 sub-conjunctival injection compared to vehicle	Day 15
Absence of pain for the 900µg XG-102 compared to vehicle	Day2

Secondary Outcome Measures

Outcome Measure	Time Frame
Use of rescue medication	up to Day 85

Other Outcome Measures

Outcome Measure	Time Frame
Specular microscopy	Day 85
Adverse event (AE) monitoring	up to Day 85

Collaborators and Investigators

• Sponsor: Xigen SA
• Investigators: Principal Investigator: Steven M Silverstein, MD, Silverstein Eye Centers

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 5, 2014
• First Submitted That Met QC Criteria: September 5, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Lens Diseases; Inflammation; Cataract; Uveitis
• Other Study ID Numbers: SDD-1002-064