NCT02585648

Brief Summary

Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. Relief of symptoms in patients with moderate to severe dry eye disease is usually reached by the use of artificial tears during the day. Nighttime relief is often achieved by substances known to be more adhesive to the ocular surface, such as gels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

April 26, 2015

Last Update Submit

March 22, 2017

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction when awakening (VAS)

    4 weeks

Secondary Outcomes (6)

  • Quality of life

    4 weeks

  • Number of drops of Thealoz Duo instilled during the day (patient diary)

    4 weeks

  • Tear break up time

    4 weeks

  • Conjunctival and corneal staining

    4 weeks

  • Schirmer 1 Test

    4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Patients with dry eye syndrome 1

EXPERIMENTAL

20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2

Device: Thealoz Duo Gel and Thealoz Duo eye dropsDevice: Thealoz Duo eye drops

Patients with dry eye syndrome 2

EXPERIMENTAL

20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1

Device: Thealoz Duo Gel and Thealoz Duo eye dropsDevice: Thealoz Duo eye drops

Interventions

Thealoz Duo Gel and Thealoz Duo eye dropsDEVICE

Thealoz Duo gel at night (1 drop before going to bed) + Thealoz Duo eye drops during the day (4 to 6 drops per day)

Also known as: Intervention 1
Patients with dry eye syndrome 1Patients with dry eye syndrome 2
Thealoz Duo eye dropsDEVICE

Thealoz Duo eye drops during the day (4 to 6 drops per day)

Also known as: Intervention 2
Patients with dry eye syndrome 1Patients with dry eye syndrome 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged over 18 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 ≤ 5 mm and ≥ 2mm
  • OSDI ≥ 22
  • Normal ophthalmic findings except dry eye syndrome
  • No administration of topical lubricants 24 hours before the screening examination

You may not qualify if:

  • Presence of an ocular pathology judged by the investigator as incompatible with the study.
  • Any other clinical relevant ocular abnormality except DES.
  • History of allergy, known hypersensitivity to one of the components: the administered medical device product, fluorescein or lissamine green
  • History of known clinically relevant allergy
  • Medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplastic, hematological disease; severe psychiatric illness, etc.).
  • Pregnancy, lactation.
  • Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilized.
  • Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses).
  • Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment.
  • Participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PD Dr.

Study Record Dates

First Submitted

April 26, 2015

First Posted

October 23, 2015

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

November 1, 2016

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

AU(1)