Assessment of Tear Film Thickness by Optical Coherence Tomography in Healthy Subjects and Subjects With Dry Eye Disease

NCT01753596 | Withdrawn Phase 3 DMC

• 1 other identifier: OPHT-200612
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Dry eye syndrome (DES) is a highly prevalent ocular condition with severe consequences for the patients reaching from ocular discomfort in its simplest form up to visual impairment and corneal ulceration in severe cases. Data from epidemiological studies indicate that DES is a common disease, especially in the elderly population, affecting up to 20% of adults aged 45 years or older. Topical lubricants are a mainstay of therapy, but data on its effect on tear film thickness and the corneal residence time are lacking. Recently, a new objective method for assessment of tear film thickness by optical coherence tomography has been developed. The present study aims to investigate the corneal residence time of an established topical lubricant compared to placebo in patients with DES and healthy controls.

Conditions

Dry Eye Syndrome

Keywords

topical lubricants; tear film thickness; break up time; ocular surface disease index; Schirmer I test

Outcome Measures

Primary Outcomes (1)

• Tear film thickness

  change from baseline to 1 hour after administration

Secondary Outcomes (3)

• Schirmer I Test

  1 day

• Tear Break Up Time

  1 day

• Ocular Surface Disease Index

  1 day

Study Arms (2)

30 healthy subjects

EXPERIMENTAL

Subjects will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo

Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland); Other: Physiological Sodium Chloride solution (0,9%)

30 patients with dry eye syndrome

EXPERIMENTAL

Patients will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo

Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland); Other: Physiological Sodium Chloride solution (0,9%)

Interventions

GENTEAL HA® Eye Drops (NOVARTIS, Switzerland) DEVICE

30 healthy subjects; 30 patients with dry eye syndrome

Physiological Sodium Chloride solution (0,9%) OTHER

Placebo

30 healthy subjects; 30 patients with dry eye syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged over 18 years
• Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
• Normal ophthalmic findings, ametropia \< 6 Dpt
• Schirmer I test \> 10 mm and BUT \> 10 sec
• Men and women aged over 18 years
• Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant except DES
• Normal ophthalmic findings, ametropia \< 6 Dpt
• History of dry eye syndrome for at least 3 months
• Tear Break Up Time (BUT) \< 10 seconds or Schirmer I test \< 7 mm
• At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching)
• Normal ophthalmic findings except dry eye syndrome

You may not qualify if:

• Regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
• Treatment in the previous 3 weeks with any drug
• Symptoms of a clinically relevant illness in the 3 weeks before the first study day
• Ametropia \>= 6 Dpt
• Pregnancy
• Difference of more than 3 mm in Schirmer I test or difference of \> 3 sec in BUT between the two eyes
• Known medical history of allergy, hypersensitivity or poor tolerance to any components of the medication or medical product used in the study

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 20, 2012
• Study Start: December 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

AU (1)