DEXTENZA Compared to Topical Steroid Therapy Prior to Cataract Surgery in Patients Who Receive Premium Intraocular Lenses

The investigators seek to assess the effect of pre-operative and continued post-operative corticosteroid use on pain, patient preference, visual outcomes, and change in objective quantifiable biological parameters in patients undergoing bilateral cataract surgery with premium intraocular lens implantation with or without baseline ocular surface disease.

Patient's first eye scheduled for surgery will receive an intracanalicular insertion of DEXTENZA (dexamethasone release profile of QID, TID, BID, QD, over 30 days; study eye). The fellow-eye will receive topical prednisolone acetate 1% (tapering schedule of QID, TID, BID, QD over 30 days). The fellow-eye design in n=30 patients (60 eyes) allows for balance in patient baseline demographic and systemic characteristics.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Drug: Dexamethasone; Drug: Prednisolone Acetate 1% Oph Susp

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Vineland, New Jersey, United States, 08361
      • Eye Associates of Vineland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Age 18 or greater with plans to undergo bilateral clear cornea cataract surgery with phacoemulsification and implantation of a premium posterior chamber IOL

  • Schirmer's test score (anesthetized) ≥ 5 mm at Screening in either eye.
  • TBUT ≤ 7 seconds at Screening or Baseline in either eye.
  • All subjects must provide signed written consent prior to participation in any study-related procedures. Able to comply with study requirements and visit schedule.

Exclusion Criteria:

• revious corneal surgery or pathology

  • Active or history of chronic or recurrent inflammatory eye disease in either eye
  • Ocular pain in either eye
  • Proliferative diabetic retinopathy in either eye
  • Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye
  • Laser or incisional ocular surgery during the study period and 6 months prior in either eye
  • Prescription and OTC ophthalmic mast cell stabilizers and antihistamines within 21 days prior to Screening and throughout the study period (systemic mast cell stabilizers are allowed, and systemic antihistamines are permitted)
  • Chronic daily use (defined as > 7 consecutive days at the recommended dosing frequency) of systemic narcotics for any chronic pain syndrome (eg, fibromyalgia, rheumatoid arthritis, etc.) during the study period.
  • Ophthalmic artificial tear drop use within 2 hours prior to any study visit. Any OTC artificial tear (preserved or unpreserved) should be continued at the same frequency and with no change in drop brand.
  • Use of any topical prescription ophthalmic medications (including cyclosporine [Restasis®, Cequa®] or topical lifitegrast [Xiidra®], steroids, nonsteroidal anti- inflammatory drugs [NSAIDs], anti-glaucoma medications within 7 days or during study period
  • Participation in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
  • Corticosteroids (intranasal, inhaled, topical dermatological, and perianal steroids) within 30 days prior to entry in the study are not permitted
  • Pregnant or breast-feeding women, women who wish to become pregnant during the length of study participation, or women of child-bearing potential.
  • Use of systemic NSAID greater than 375 mg per day.
  • Glaucoma or is on medications to treat glaucoma.
  • Ocular Hypertension, defined as IOP of >21 mmHg, is on medications to treat hypertension or has a history of IOP spikes in either eye including steroid-related IOP increases.
  • Presence of nasolacrimal duct obstruction or history of cauterization of the Punctum.
  • Active epiphora or clinically significant dry eye syndrome.
  • Know allergy or sensitivity to the investigational product or its components.
  • The Investigator determines that the subject should not be included for reasons not already specified (e.g, systemic or other ocular disease/abnormality) if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dextenza insert; Patient's first eye scheduled for surgery will receive an intracanalicular insertion of DEXTENZA (dexamethasone release profile of QID, TID, BID, QD, over 30 days; study eye).	Drug: Dexamethasone; Treatment of pain and inflammation following ophthalmic surgery
Other: Fellow-eye; The fellow-eye will receive topical prednisolone acetate 1% (tapering schedule of QID, TID, BID, QD over 30 days). The fellow-eye design in n=30 patients (60 eyes) allows for balance in patient baseline demographic and systemic characteristics.	Drug: Prednisolone Acetate 1% Oph Susp; Topical steroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scale	Proportion of eyes with absence of pain as measured by pain scale (pain score = 0) from Baseline over each time point through Day 30. Subjects will use the Ocular Pain Assessment scale. A 0-10 point scale, where 0 is the least pain and 10 is the greatest pain, subjects will be asked to rank their level of pain.	30 days

Collaborators and Investigators

• Sponsor: Prism Vision Group

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: DEXTENZA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No