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

Phase 1

• Conditions: conjunctival bacterial flora in patients with dry eye syndrome; MedDRA version: 19.1Level: LLTClassification code 10013777Term: Dry eye syndromeSystem Organ Class: 100000004853; Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

• Registration Number: EUCTR2015-002507-28-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-23
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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 < 6 Dpt.
- Recommended use of topical lubricants, but no administration of topical lubricants 4 weeks preceding the first study day.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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