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

NCT02508337 | Completed Phase 3

• 1 other identifier: SDD-1002-065
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Absence of anterior chamber cells

  Day 15

• Pain scores as measured by the visual analog scale

  Day2

Secondary Outcomes (2)

• Use of rescue medication

  up to D22

• Number of patients with adverse events

  up to D22

Study Arms (2)

XG-102

EXPERIMENTAL

sterile ophthalmic solution for sub-conjunctival injection

Drug: XG-102

placebo

PLACEBO COMPARATOR

sterile ophthalmic solution for sub-conjunctival injection

Drug: Placebo

Interventions

XG-102 DRUG

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

XG-102

Placebo DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Xigen SA: lead

Study Sites (1)

Ora

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Inflammation; Pain; Cataract

Interventions

D-JNKI-1

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Lens Diseases; Eye Diseases

Study Officials

• Juli Chalifour

  ORA, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 24, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

US (1)