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NCT04184999

Effect of Intraoperative Dexamethasone on Post-op Dry Eye

Completed Phase 4 Results posted Last updated 22 November 2023
What this trial tests

Phase 4 trial testing dexamethasone intraocular suspension, 9% in Dry Eye Syndromes in 40 participants. Completed in 1 December 2019.

Timeline
10 August 2019
Primary endpoint
1 December 2019
1 December 2019

Quick facts

Lead sponsorSR Cornea Consultants
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment40
Start date10 August 2019
Primary completion1 December 2019
Estimated completion1 December 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

SR Cornea Consultants — full company profile →

Who can join

Adults 18 to 90, any sex, with Dry Eye Syndromes. 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.

Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively Primary · 3 weeks

Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L)

GroupValue95% CI
Intracameral Dexamethasone311.15284 – 333
Postoperative Prednisolone Acetate316.3286 – 335

Sponsor's own description

To compare the signs and symptoms of dry eye after cataract surgery between subjects randomized to receive intraoperative dexamethasone in addition to the use of a standard topical post-op treatment regimen.

Publications & conference data

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

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Other recruiting trials for Dry Eye Syndromes

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04184999.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing