Clinical trial NCT02235272: Efficacy and Safety of XG-102 in Reduction of Post-cataract Surgery Intraocular Inflammation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation
Pain
Cataract
Lead sponsor: Xigen SA
Sponsor class: INDUSTRY
First posted: 2014-09-09
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absence of anterior chamber cells for the 900µg XG-102 sub-conjunctival injection compared to vehicle
timeFrame: Day 15
measure: Absence of pain for the 900µg XG-102 compared to vehicle
timeFrame: Day2
Secondary outcomes:
measure: Use of rescue medication
timeFrame: up to Day 85
Other outcomes:
measure: Specular microscopy
timeFrame: Day 85
measure: Adverse event (AE) monitoring
timeFrame: up to Day 85
Locations:
city: Garden Grove
country: United States
state: California
Study officials:
affiliation: Silverstein Eye Centers
name: Steven M Silverstein, MD
role: PRINCIPAL_INVESTIGATOR
References: