Cataract, Inflammation, Pain
Conditions
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.
Interventions
DRUGXG-102
Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery
DRUGPlacebo
Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery
Sponsors
Xigen SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of anterior chamber cells | Day 15 |
| Pain scores as measured by the visual analog scale | Day2 |
Secondary
| Measure | Time frame |
|---|---|
| Use of rescue medication | up to D22 |
| Number of patients with adverse events | up to D22 |
Countries
United States
Outcome results
None listed