"A Prospective Study of the Efficacy of Intracameral Dexamethasone (Dexycu™) Compared to Standard of Care Treatment for Post-Cataract Surgical Pain and Anterior Chamber Inflammation"

Cataract Clinical Trial

Official title:

"A Prospective Study of the Efficacy of Intracameral Dexamethasone (Dexycu™) Compared to Standard of Care Treatment for Post-Cataract Surgical Pain and Anterior Chamber Inflammation"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04781335
• Other study ID #: EIWF-EP001
• Status: Recruiting
• Phase: Phase 4
• Start date: February 20, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: February 2021
• Source: The Eye Institute of West Florida
• Contact: Renee Bondurant, BS
• Phone: 727-581-8706
• Email: Renee.Bondurant[@]eyespecialist.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cataract surgery is the most common surgical procedure performed on humans today. The postoperative regimen includes a combination of steroids, NSAIDs (non-steroidal anti-inflammatory drugs) and antibiotics. Those are used to decrease the possibility of infection, inflammation that may lead to corneal and macular edema and pain management. There are several FDA approved agents either for topical use as single drug delivery or combination solutions for topical use as well; furthermore, there are slow release vehicles that may be placed at the time of surgery or postoperatively (at the lower punctum). The latter provides a less intense and demanding drop schedule and may improve patient compliance.

Description:

The current study will assess post cataract the efficacy and safety of two different FDA approved regimens, which include the standard of care (topical steroids, NSAIDs and antibiotics) or Intracameral Dexamethasone (Dexycu™) along with topical NSAIDs and antibiotics.

The hypothesis of the current study is that topical steroids or intracamerally injected steroids as slow release vehicles, demonstrate the same efficacy of controlling post cataract pain and inflammation. We will assess one objective outcome measure, anterior chamber inflammation. This will provide a direct index of the efficacy of the steroidal agents used. Furthermore, a subjective outcome measure, ocular pain, will also be assessed. In cases where a patient in either of the two groups has sever inflammation, rescue medications will be applied, increasing the dosage of topical steroidal agents and the patient will be followed closely until resolved.

The study will include 50 consecutive patients, men and women ages 40 to 90 years old, with visually significant cataract that received bilateral cataract surgery using either the manual technique or femtosecond assisted cataract surgery. Bilateral surgery is common practice and is not performed on the same day. There is a one week time interval between the eyes receiving cataract extraction. The patients that we will enroll in the suggested study will require and will receive bilateral cataract surgery with one week time interval between the two eyes. There are no restrictions on racial or ethnic origin. Employees of The Eye Institute of West Florida will not be enrolled into this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• • Patients age 40 to 90 years old, with visually significant cataract that received bilateral cataract surgery using either the manual technique or femtosecond assisted cataract surgery

Exclusion Criteria:

• • Patients with history of diabetes mellitus and other systemic conditions that may promote inflammation

• patients with previous ocular disease history

• patients with history of ocular surgery

• patients using prescription eye medications topically

• vulnerable subjects or subjects with diminished capacity requiring a POA (Power of Attorney)

• patients with allergies to steroids, NSAID's, or besifloxacin (standard antibiotic)

• women who are pregnant or lactating

Related Conditions & MeSH terms

• Cataract
• Inflammation

Intervention

Drug:
• Dexycu
This is a contra-lateral randomized study, meaning that in clinic after a patient is identified as a candidate we will "flip a coin" for selection of the eye that is going to receive the Dexycu™ implant (the implant will be placed intracapsularly at the optic haptic junction of the IOL). The patients will receive the SAME topical regimen (Eye with Dexycu™: no steroid, Eye without Dexycu™: steroid will be used). The Dexycu™, topical NSAID, and antibiotic regimen will be provided to all patients in the study, at no cost, in order to avoid difficulties with compliance, insurance, and follow up.
• Standard of Care post operative eye drops (steroid, antibiotic, NSAID)
This is a contra-lateral randomized study, meaning that in clinic after a patient is identified as a candidate we will "flip a coin" for selection of the eye that is going to receive the Dexycu™ implant (the implant will be placed intracapsularly at the optic haptic junction of the IOL). The patients will receive the SAME topical regimen (Eye with Dexycu™: no steroid, Eye without Dexycu™: steroid will be used). The Dexycu™, topical NSAID, and antibiotic regimen will be provided to all patients in the study, at no cost, in order to avoid difficulties with compliance, insurance, and follow up.

Locations

Country	Name	City	State
United States	The Eye Institute of West Florida	Largo	Florida

Sponsors (2)

Lead Sponsor	Collaborator
The Eye Institute of West Florida	EyePoint Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Concerning the outcome measures of pain we are going to use NRS pain (numeric rating scale score) that takes a minute to do, it is a subjective measure of pain that the patient is experiencing, the patient circles a number between 0 and 10 (0 no pain and 10 worse pain imaginable). Score 0 will be considered as no pain and any score equal or more than 5 will be considered as moderate to severe pain.	post operative day 1
Primary	Pain score	Concerning the outcome measures of pain we are going to use NRS pain (numeric rating scale score) that takes a minute to do, it is a subjective measure of pain that the patient is experiencing, the patient circles a number between 0 and 10 (0 no pain and 10 worse pain imaginable). Score 0 will be considered as no pain and any score equal or more than 5 will be considered as moderate to severe pain.	post operative day 7
Primary	Pain score	Concerning the outcome measures of pain we are going to use NRS pain (numeric rating scale score) that takes a minute to do, it is a subjective measure of pain that the patient is experiencing, the patient circles a number between 0 and 10 (0 no pain and 10 worse pain imaginable). Score 0 will be considered as no pain and any score equal or more than 5 will be considered as moderate to severe pain.	post operative day 30
Primary	Inflammation Score	Concerning the outcome measures of cell and flare we are going to use SOIS (summed ocular inflammation score).	post operative day 1
Primary	Inflammation Score	Concerning the outcome measures of cell and flare we are going to use SOIS (summed ocular inflammation score).	post operative day 7
Primary	Inflammation Score	Concerning the outcome measures of cell and flare we are going to use SOIS (summed ocular inflammation score).	post operative day 30