Clinical Trials Logo
  1. Home
  2. Eye Diseases
  3. NCT00414739
  4. Details
NCT00414739 Clinical Trial

Testing of Innocuousness of Benzalkonium Chloride on the Eye Concerning Possible Growth of Langerhans Cells

Eye Diseases Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00414739
Other study ID # BAC-2006-1
Secondary ID
Status Recruiting
Phase Phase 1
First received December 21, 2006
Last updated December 21, 2006

Study information
Verified date December 2006
Source University of Rostock
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The study analysis the influence of benzalkonium chloride on the density of antigen presenting Langerhans cells. This is achieved in a double blind randomized study using in-vivo confocal microscopy to identify and quantify Langerhans cells of the human cornea in its central and peripheral part. This study design is based on observations with raised Langerhans cell density after the application of benzalkonium chloride containing eye drops in glaucoma patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- healthy probands

Exclusion Criteria:

- eye diseases

- pregnancy and lactation period

- drug dependency

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Benzalkonium chloride

Locations
Country Name City State
Germany University of Rostock, Eye Department Rostock

Sponsors (2)
Lead Sponsor Collaborator
University of Rostock Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Becquet F, Goldschild M, Moldovan MS, Ettaiche M, Gastaud P, Baudouin C. Histopathological effects of topical ophthalmic preservatives on rat corneoconjunctival surface. Curr Eye Res. 1998 Apr;17(4):419-25. — View Citation

De Saint Jean M, Brignole F, Bringuier AF, Bauchet A, Feldmann G, Baudouin C. Effects of benzalkonium chloride on growth and survival of Chang conjunctival cells. Invest Ophthalmol Vis Sci. 1999 Mar;40(3):619-30. — View Citation

Eckard A, Stave J, Guthoff RF. In vivo investigations of the corneal epithelium with the confocal Rostock Laser Scanning Microscope (RLSM). Cornea. 2006 Feb;25(2):127-31. — View Citation

Noecker R. Effects of common ophthalmic preservatives on ocular health. Adv Ther. 2001 Sep-Oct;18(5):205-15. Review. — View Citation

Zhivov A, Stachs O, Kraak R, Stave J, Guthoff RF. In vivo confocal microscopy of the ocular surface. Ocul Surf. 2006 Apr;4(2):81-93. Review. — View Citation

Zhivov A, Stave J, Vollmar B, Guthoff R. In vivo confocal microscopic evaluation of Langerhans cell density and distribution in the normal human corneal epithelium. Graefes Arch Clin Exp Ophthalmol. 2005 Oct;243(10):1056-61. Epub 2005 Oct 20. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Possible raised Langerhans cell density in the corneal epithelium
See also
  Status Clinical Trial Phase
Recruiting NCT05414994 - Assessment of the Ocular Microbiome in Health and Disease
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Completed NCT02811692 - Study for Collection of Aflibercept Data in Routine Practice
Recruiting NCT06045299 - Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia Phase 3
Recruiting NCT01521065 - An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Phase 2
Completed NCT04799704 - Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic Patients.
Recruiting NCT05876689 - Swept Source OCT Imaging With the DREAM VG-OCT
Active, not recruiting NCT04123626 - A Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects With Autosomal Dominant Retinitis Pigmentosa Due to the P23H Mutation in the RHO Gene Phase 1/Phase 2
Recruiting NCT04150432 - Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children N/A
Not yet recruiting NCT05550740 - Repeated Low-Level Red-Light Therapy for Shortening Axial Length N/A
Completed NCT02332343 - Sparing of the Fovea in Geographic Atrophy Progression N/A
Completed NCT01727973 - Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy Phase 1/Phase 2
Terminated NCT01225146 - Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2) Phase 1
Completed NCT00333203 - Next Generation Ophthalmic Irrigating Solution Posterior Segment Study Phase 3
Not yet recruiting NCT05565547 - Multimodal Equipment for Teleophthalmology Assessment (META)
Recruiting NCT05158699 - Effectiveness of Periocular Drug Injection in CATaract Surgery Phase 3
Recruiting NCT06112340 - A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) Phase 2/Phase 3
Recruiting NCT06451172 - Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis Early Phase 1
Completed NCT05211089 - Manual Versus Automated Choroidal Thickness Measurements Using Swept-source Anterior Segment OCT
Not yet recruiting NCT06070467 - Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases