NCT05853978 is a Phase 4 clinical trial of BSS Plus in Fuchs Dystrophy, sponsored by Adam Fedyk, MD, FACS.

Who is sponsoring NCT05853978?

NCT05853978 is sponsored by Adam Fedyk, MD, FACS.

What drugs are being tested in NCT05853978?

Interventions in NCT05853978: BSS Plus, BSS.

What condition does NCT05853978 study?

NCT05853978 studies Fuchs Dystrophy, Cataract.

Is NCT05853978 still recruiting?

NCT05853978 is currently completed. Last updated 3 July 2025.

Last reviewed 2025-07-03 · How we verify

NCT05853978

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Evaluation of Balanced Salt Solution During Cataract Surgery

Completed Phase 4 Last updated 3 July 2025

What this trial tests

Phase 4 trial testing BSS Plus in Fuchs Dystrophy in 26 participants. Completed in 31 March 2025.

Timeline

17 April 2023

Primary endpoint
21 February 2025

31 March 2025

Quick facts

Lead sponsor	Adam Fedyk, MD, FACS
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	supportive care
Enrollment	26
Start date	17 April 2023
Primary completion	21 February 2025
Estimated completion	31 March 2025
Sites	1 location across United States

Drugs / interventions tested

BSS Plus — full drug profile →
BSS (SODIUM CITRATE) — full drug profile →

Conditions studied

Fuchs Dystrophy — all drugs for Fuchs Dystrophy →
Cataract — all drugs for Cataract →

Sponsor

Adam Fedyk, MD, FACS — full company profile →

Who can join

22 and older, any sex, with Fuchs Dystrophy or Cataract. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to identify if the use of BSS PLUS® Sterile Intraocular Irrigating Solution as an irrigation solution leads to improved corneal outcomes vs BSS® Sterile Irrigating Solution in more compromised corneas.

Publications & conference data

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

Verify or expand the search:

Other recruiting trials for Fuchs Dystrophy

Currently open trials in the same condition.

NCT06881771 — FECD-TRACE: Fuchs' Endothelial Corneal Dystrophy TRAjectory and Correlation With Genotype in the United Kingdom · recruiting
NCT05275972 — Descemet Endothelial Thickness Comparison Trial II · Phase 3 · recruiting
NCT05636579 — Study to Assess Safety and Tolerability of Multiple Doses of EO2002 · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05853978 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Adam Fedyk, MD, FACS
Last refreshed: 3 July 2025

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/NCT05853978.

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