Effect of preservative containing eye drops on the conjunctival bacteria of patients with dry eye syndrome.

Effect of benzalkonium chloride containing eye drops on the conjunctival bacterial flora of dry eye patients. - Dry Eye BAC conjunctiva

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002507-28-AT

Enrollment

Registered

2015-06-23

Start date

2015-07-20

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

conjunctival bacterial flora in patients with dry eye syndrome MedDRA version: 19.1 Level: LLT Classification code 10013777 Term: Dry eye syndrome System Organ Class: 100000004853

Interventions

Trade Name: Prosicca Pharmaceutical Form: Eye drops INN or Proposed INN: Hydroxypropylmethylcellulose Other descriptive name: METHYL HYDROXYPROPYL CELLULOSE Concentration unit: 1X 100 milligrams/milli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Men and women aged between 18 and 75 years. - Signed and dated written informed consent. - History of dry eye syndrome for at least 3 months - Tear Break Up Time (BUT) = 10 seconds or Schirmer I test = 10 mm and = 2mm - Normal ophthalmic findings except dry eye syndrome, ametropia =65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: - History or presence of ocular disease judged by the investigator as incompatible with the study. - Any other topical ocular treatment than the study medication in the 4 weeks preceding the first study day and during the treatment period. - Wearing of contact lenses. - Symptoms of a clinically relevant illness in the 3 weeks before the first study day - Participation in a clinical trial in the 3 weeks preceding the first study day - Pregnancy, lactation.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of benzalkonium chloride containing eye drops on the conjunctival bacterial flora of patients with mild or moderate dry eye syndrome.;Secondary Objective: not applicable;Primary end point(s): Number of colony forming units (CFU) in bacterial culture of conjunctival swab;Timepoint(s) of evaluation of this end point: before and after the 4-week treatment period	—

Measure

Time frame

Main Objective: To investigate the effect of benzalkonium chloride containing eye drops on the conjunctival bacterial flora of patients with mild or moderate dry eye syndrome.;Secondary Objective: not applicable;Primary end point(s): Number of colony forming units (CFU) in bacterial culture of conjunctival swab;Timepoint(s) of evaluation of this end point: before and after the 4-week treatment period

—

Secondary

Measure	Time frame
Secondary end point(s): - Tear Break Up Time (BUT) - Schirmer I test - OSDI© score ;Timepoint(s) of evaluation of this end point: before and after the 4-week treatment period	—

Countries

Austria

Contacts

Public ContactDepartment of Clinical Pharmacology

Medical University of Vienna

klin-pharmakologie@meduniwien.ac.at+4314040029810

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026