- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02508337
Efficacy and Safety of XG-102 in Reduction of Post-cataract Surgery Intraocular Inflammation and Pain
January 23, 2017 updated by: Xigen SA
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
309
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Andover, Massachusetts, United States, 01810
- Ora
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: XG-102
sterile ophthalmic solution for sub-conjunctival injection
|
Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery
|
Placebo Comparator: placebo
sterile ophthalmic solution for sub-conjunctival injection
|
Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absence of anterior chamber cells
Time Frame: Day 15
|
Day 15
|
Pain scores as measured by the visual analog scale
Time Frame: Day2
|
Day2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Use of rescue medication
Time Frame: up to D22
|
up to D22
|
Number of patients with adverse events
Time Frame: up to D22
|
up to D22
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Juli Chalifour, ORA, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
July 20, 2015
First Submitted That Met QC Criteria
July 22, 2015
First Posted (Estimate)
July 24, 2015
Study Record Updates
Last Update Posted (Estimate)
January 24, 2017
Last Update Submitted That Met QC Criteria
January 23, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDD-1002-065
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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