"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"

NCT04781335 | Completed Phase 4 FDA Drug

• 1 other identifier: EIWF-EP001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract

Keywords

Cataract; Dexycu

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• Inflammation Score

  Concerning the outcome measures of cell and flare we are going to use SOIS (summed ocular inflammation score).

  post operative day 1

• Inflammation Score

  Concerning the outcome measures of cell and flare we are going to use SOIS (summed ocular inflammation score).

  post operative day 7

• Inflammation Score

  Concerning the outcome measures of cell and flare we are going to use SOIS (summed ocular inflammation score).

  post operative day 30

Study Arms (2)

Dexycu

ACTIVE COMPARATOR

Drug: Dexycu

Standard Care Post operative drops

ACTIVE COMPARATOR

Drug: Standard of Care post operative eye drops (steroid, antibiotic, NSAID)

Interventions

Dexycu DRUG

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.

Dexycu

Standard of Care post operative eye drops (steroid, antibiotic, NSAID) DRUG

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 Care Post operative drops

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Eye Institute of West Florida: lead
• EyePoint Pharmaceuticals, Inc.: collaborator

Study Sites (1)

The Eye Institute of West Florida

Largo, Florida, 33770, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Calcium Dobesilate; Steroids; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Fused-Ring Compounds; Polycyclic Compounds; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents

Study Officials

• Robert J Weinstock, MD

  The Eye Institute of West Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: March 4, 2021
• Study Start: February 20, 2020
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)