NCT05372315: DEXTENZA

Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.

Completed Phase 4 Results posted Last updated 23 August 2023

What this trial tests

Phase 4 trial testing Dextenza 0.4Mg Ophthalmic Insert in Cataract in 80 participants. Completed in 31 October 2022.

Timeline

15 June 2022

Primary endpoint
31 October 2022

31 October 2022

Quick facts

Lead sponsor	Iworks Laser and Vision Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	15 June 2022
Primary completion	31 October 2022
Estimated completion	31 October 2022
Sites	1 location across United States

Drugs / interventions tested

• Dextenza 0.4Mg Ophthalmic Insert — full drug profile →

Conditions studied

• Cataract — all drugs for Cataract →

Sponsor

Iworks Laser and Vision Center

Who can join

Adults 18 to 100, any sex, with Cataract. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participants With Complete Absence of Ocular Pain at Day 8 Primary · at Day 8

Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8.

Group	Value	95% CI
Lower Punctum Insertion (Group 1)	39
Lower Punctum Insertion (Group 2)	39
Lower Punctum Insertion (Group 1)	0
Lower Punctum Insertion (Group 2)	1

Participants With Zero Cells on Day 14 Primary · at Day 14

Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4).

Group	Value	95% CI
Lower Punctum Insertion (Group 1)	38
Upper Punctum Insertion (Group 2)	37
Lower Punctum Insertion (Group 1)	1
Upper Punctum Insertion (Group 2)	3

Ease of Insertion Secondary · Day 0

Rated as Easy, Moderate, Difficult

Easy

Group	Value	95% CI
Lower Punctum Insertion (Group 1)	36
Upper Punctum Insertion (Group 2)	36

Moderate

Group	Value	95% CI
Lower Punctum Insertion (Group 1)	2
Upper Punctum Insertion (Group 2)	4

Difficult

Group	Value	95% CI
Lower Punctum Insertion (Group 1)	1
Upper Punctum Insertion (Group 2)	0

Attempts to Achieve Successful Insertion Secondary · Day 0

Number of attempts to insert the dexamethasone insert in the upper or lower punctum.

One Attempt

Group	Value	95% CI
Lower Punctum Insertion (Group 1)	38
Upper Punctum Insertion (Group 2)	35

Two Attempts

Group	Value	95% CI
Lower Punctum Insertion (Group 1)	1
Upper Punctum Insertion (Group 2)	5

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lower Punctum Insertion (Group 1)

Serious: 0/39 (0%)

Deaths: 0/39

Upper Punctum Insertion (Group 2)

Serious: 0/40 (0%)

Deaths: 0/40

Other adverse events (6 terms — click to expand)

Reaction	System	Lower Punctum Insertion (G…	Upper Punctum Insertion (G…
Increased IOP	Eye disorders	—	—
CME	Eye disorders	—	—
Blurred Vision	Eye disorders	—	—
Anterior Chamber Inflammation	Eye disorders	—	—
Corneal Edema	Eye disorders	—	—
Insert Fell Out	Eye disorders	—	—

Data from ClinicalTrials.gov NCT05372315 adverse events section.

Sponsor's own description

To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.