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OpenTrials
Completed

NCT Number: NCT02585648

Added Benefits of Lachrymal Substitute Gel During the Night in Patients With Moderate to Severe Dry Eye Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.).
  • History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).
  • 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.

Treatment and study plan

Thealoz Duo Gel and Thealoz Duo eye drops

Device

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

Other names: Intervention 1

Thealoz Duo eye drops

Device

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

Other names: Intervention 2

Primary outcomes

  1. Patient satisfaction when awakening (VAS)

    Time frame: 4 weeks

Secondary outcomes

  1. Quality of life

    Time frame: 4 weeks

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

    Time frame: 4 weeks

  3. Tear break up time

    Time frame: 4 weeks

  4. Conjunctival and corneal staining

    Time frame: 4 weeks

  5. Schirmer 1 Test

    Time frame: 4 weeks

  6. OSDI questionnaire

    Time frame: 4 weeks

    Ocular Surface Disease Index Questionnaire

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2015
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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