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AzTrials

HealthyPhase 3NCT01746602

Effect of Topical Glaucoma Therapy on Tear Film Stability in Healthy Subjects

A Phase 3 study testing Timoptic® 0.5%, Timophtal sine® 0.5% and Genteal HA® in people with Healthy, run by Medical University of Vienna at 1 site in Austria.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Long term treatment with anti-glaucomatous drugs has been shown to increase the incidence of dry eye syndrome with all known consequences such as ocular discomfort and epithelial keratitis. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Timoptic® 0.5%, Timophtal sine® 0.5% and Genteal HA®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteAustria
Study dates
Jul 2011to Jan 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men and women aged over 18 years
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropia < 6 Dpt.

Who cannot join

  • 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
  • Patients with known hypersensitivity to the study drug or any ingredients
  • History or current COPD or asthma
  • AV-block grade II or more
  • Ametropy ≥ 6 Dpt
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Department of Clinical Pharmacology, Medical University of Vienna

    Vienna, State of Vienna, 1090

Other trials in Austria

About this study

Long term treatment with anti-glaucomatous drugs has been shown to increase the incidence of dry eye syndrome with all known consequences such as ocular discomfort and epithelial keratitis. Given that thinning of the tear film appears to be a risk factor for the development or the aggravation of dry eye syndrome, the current study seeks to investigate whether tear film thickness is changed after topical treatment with anti-glaucomatous drugs in healthy subjects.

For this purpose, tear film thickness will be measured at baseline and after single instillation of one of 5 study drugs in one randomly chosen eye. In addition, one group of 20 subjects will receive no drug and will serve as a second control. Drug effects on tear film thickness will be compared to the fellow, non-treated eye. In addition, effects on tear film thickness of timolol with preservatives (Timoptic 0.5%) will be compared to timolol without preservatives (Timophtal sine 0.5%) and three lubricants with different viscosity (Genteal HA, Hylo-Comod, Thealoz).

Conditions
Healthy
Being tested
Timoptic® 0.5%, Timophtal sine® 0.5%, Genteal HA®, Hylo-Comod®, Thealoz®
Keywords
topical lubricants, tear film thickness, anti-glaucoma drugs, break up time, anti-glaucoma treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Timoptic® 0.5%Drug

    Timoptic® 0.5% Eye Drops, Merck, single instillation

  • Timophtal sine® 0.5%Drug

    Timophtal sine® 0.5%, Agepha, Eye Drops, single instillation

  • Genteal HA®Device

    Genteal HA® Eye Drops, Novartis, single instillation

  • Hylo-Comod®Device

    Hylo-Comod® Eye Drops, Croma-Pharma, single instillation

  • Thealoz®Device

    Thealoz® Eye Drops, Thea, France, single instillation

Study groups in NCT01746602
Study groupRoleWhat they receive
healthy subjects IExperimental20 healthy subjects
Receives: Drug: Timoptic® 0.5%
healthy subjects IIExperimental20 healthy subjects
Receives: Drug: Timophtal sine® 0.5%
healthy subjects IIIExperimental20 healthy subjects
Receives: Device: Genteal HA®
healthy subjects IVExperimental20 healthy subjects
Receives: Device: Hylo-Comod®
healthy subjects VExperimental20 healthy subjects
Receives: Device: Thealoz®
healthy subjects VINo intervention20 healthy subjects

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tear film thickness

    Measured: up to 1 hour

Secondary outcomes (1)

  1. Break up time (BUT)

    Measured: once on the study day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2012 (estimated)
  2. Study startJul 2011
  3. Primary completionSep 2012
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01746602
Sponsor's protocol ID
OPHT-241010
Status last verified
Dec 2016
First submitted
7 Dec 2012
Last updated
2 Dec 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Werkmeister RM, Alex A, Kaya S, Unterhuber A, Hofer B, Riedl J, Bronhagl M, Vietauer M, Schmidl D, Schmoll T, Garhofer G, Drexler W, Leitgeb RA, Groeschl M, Schmetterer L. Measurement of tear film thickness using ultrahigh-resolution optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 Aug 15;54(8):5578-83. doi: 10.1167/iovs.13-11920.

    PubMed 23847319

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Timoptic® 0.5%, Timophtal sine® 0.5% and Genteal HA® in people with Healthy, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tear film thickness (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01746602, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2016.

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