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

NCT04479748 | Completed Phase 4 FDA Drug

• 1 other identifier: DEXTENZA
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dextenza insert

OTHER

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

Fellow-eye

OTHER

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

Interventions

Dexamethasone DRUG

Treatment of pain and inflammation following ophthalmic surgery

Dextenza insert

Prednisolone Acetate 1% Oph Susp DRUG

Topical steroid

Fellow-eye

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prism Vision Group: lead

Study Sites (1)

Eye Associates of Vineland

Vineland, New Jersey, 08361, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Dexamethasone; prednisolone acetate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: October 1, 2020
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)