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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235272
• Other study ID #: SDD-1002-064
• Status: Completed
• Phase: Phase 3
• First received: September 5, 2014
• Last updated: January 23, 2017
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: Xigen SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Pain
• Uveitis

Intervention

Drug:
• XG-102
Comparison of XG-102 versus placebo sub-conjunctival injection efficacy
• Placebo
comparison of XG-102 versus placebo sub-conjunctival injection efficacy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xigen SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Specular microscopy		Day 85
Other	Adverse event (AE) monitoring		up to Day 85
Primary	Absence of anterior chamber cells for the 900µg XG-102 sub-conjunctival injection compared to vehicle		Day 15
Primary	Absence of pain for the 900µg XG-102 compared to vehicle		Day2
Secondary	Use of rescue medication		up to Day 85