Overview

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

Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xigen SA
Treatments:
Ophthalmic Solutions
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