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

NCT ID: NCT02508337

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 309 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-03-31

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.

Conditions

Inflammation; Pain; Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

XG-102

sterile ophthalmic solution for sub-conjunctival injection

Group Type: EXPERIMENTAL

XG-102

Intervention Type: DRUG

Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery

placebo

sterile ophthalmic solution for sub-conjunctival injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery

Interventions

XG-102

Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery

Intervention Type: DRUG

Placebo

Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xigen SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juli Chalifour

Role: STUDY_DIRECTOR

ORA, Inc.

Locations

Ora

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

SDD-1002-065

Identifier Type: -

Identifier Source: org_study_id