NCT01375582 is a EARLY_PHASE1 clinical trial of B & L Soothe Lubricant Eye Drops in Dry Eye, sponsored by University of Rochester.

Who is sponsoring NCT01375582?

NCT01375582 is sponsored by University of Rochester.

What drugs are being tested in NCT01375582?

Interventions in NCT01375582: B & L Soothe Lubricant Eye Drops, Liposic EDO, OcuFresh Eye Wash.

Is NCT01375582 still recruiting?

NCT01375582 is currently completed. Last updated 19 November 2022.

Last reviewed 2022-11-19 · How we verify

NCT01375582

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

Objective Evaluation of Ocular Surface Lubricants

Completed EARLY_PHASE1 Last updated 19 November 2022

What this trial tests

EARLY_PHASE1 trial testing B & L Soothe Lubricant Eye Drops in Dry Eye in 20 participants. Completed in 1 June 2012.

Timeline

1 June 2011

Primary endpoint
1 June 2012

1 June 2012

Quick facts

Lead sponsor	University of Rochester
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	1 June 2011
Primary completion	1 June 2012
Estimated completion	1 June 2012
Sites	1 location across United States

Drugs / interventions tested

B & L Soothe Lubricant Eye Drops — full drug profile →
Liposic EDO — full drug profile →
OcuFresh Eye Wash — full drug profile →

Conditions studied

Dry Eye — all drugs for Dry Eye →

Sponsor

University of Rochester

Who can join

Adults 30 to 75, any sex, with Dry Eye. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Tear Film Properties
Time frame: Measurements: There is no time restriction between the screening and 1st measurement. 6 measurement visits occur approximately 7 days apart but can range from 3 to 14 days. The time between visit 3 and 4 are not be closer than 3 days, but no upper limit.
The wavefront sensor instrument measures the eye's ability to create a sharp image. Ellipsometer (E) data identifies changes in lipid thickness and refractive index over the cornea. A thermal (T) imaging system provides thermal maps of the subject's eyes and face adjacent to the eyes. A questionnaire (Q) will ask subjects about their test eye's comfort. Subjects will be asked the questions prio

Sponsor's own description

This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.

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 Dry Eye

Currently open trials in the same condition.

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NCT07298811 — Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment · Phase 1, PHASE2 · recruiting
NCT07135193 — Evaluation of the Protective Effects of Cordyceps Cicadae on Visual Function and Anti-Fatigue Performance in Esports Ath · NA · active not recruiting

Other University of Rochester trials

Trials by the same sponsor.

NCT07075965 — Calcium Channel Blocker in Myotonic Dystrophy Type 1 · Phase 1 · not yet recruiting
NCT07423104 — A Study of Cladribine, Low Dose Cytarabine, and Venetoclax in Treatment of Relapsed/Refractory or Secondary Acute Myeloi · Phase 2 · not yet recruiting
NCT05744869 — SBAT for Health Equity · NA · not yet recruiting
NCT06052956 — Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses · Phase 2 · not yet recruiting
NCT07032636 — Reducing Crises and Suicide Within the Idaho Army National Guard · NA · not yet 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 NCT01375582 (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 University of Rochester
Last refreshed: 19 November 2022

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/NCT01375582.

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