Dose Tolerance Study After Ocular Administration of Tiotropium in Healthy Male Volunteers

June 26, 2014 updated by: Boehringer Ingelheim

A Single Increasing Dose Tolerance Study After Ocular Administration of Tiotropium (Single Doses: 0.02 - 0.4 mcg) in Healthy Male Volunteers (Randomised, Placebo-controlled, Double-blind, Parallel Groups).

Safety and tolerability after ocular administration

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy males
  • Age range from 21 to 50 years
  • Within ± 20% of normal weight (Broca-Index)
  • Written informed consent given

Exclusion Criteria:

  • Results of the medical examinations or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
  • Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Volunteers with disease of the central nervous system (such as epilepsy) or with psychiatric disorders
  • Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
  • Volunteers with chronic or relevant acute infections
  • Volunteers with history of allergy/ hypersensitivity (including drug allergy)
  • Volunteers with known eye diseases (incl. glaucoma), with hyperopia (> 3 diopters) or with contact lenses
  • Volunteers with intraocular pressure > 22 mmHg
  • Volunteers with predisposition to narrow-angle glaucoma
  • Volunteers with disturbed micturition
  • Volunteers who have taken a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study
  • Volunteers who received any other drugs which might influence the results of the trial during the week previous the start of the study
  • Volunteers who have participated in another study with an investigational drug within the last two months preceding this study
  • Volunteers who smoke (> 10 cigarettes or 3 cigars or 3 pipes/day)
  • Volunteers who are not able to refrain from smoking on study day
  • Volunteers who drink more than 40 g of alcohol per day
  • Volunteers who are dependent on drugs
  • Volunteers who have donated blood (≥ 100 ml) within the last four weeks
  • Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tiotropium dose group 1
0.02 mcg tiotropium solution
Drug: 0.02 mcg tiotropium solution
Drug: Placebo solution
Experimental: Tiotropium dose group 2
0.04 mcg tiotropium solution
Drug: Placebo solution
Drug: 0.04 mcg tiotropium solution
Experimental: Tiotropium dose group 3
0.08 mcg tiotropium solution
Drug: Placebo solution
Drug: 0.08 mcg tiotropium solution
Experimental: Tiotropium dose group 4
0.16 mcg tiotropium solution
Drug: Placebo solution
Drug: 0.16 mcg tiotropium solution
Experimental: Tiotropium dose group 5
0.28 mcg tiotropium solution
Drug: Placebo solution
Drug: 0.28 mcg tiotropium solution
Experimental: Tiotropium dose group 6
0.40 mcg tiotropium solution
Drug: Placebo solution
Drug: 0.40 mcg tiotropium solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in pupil diameter
Time Frame: baseline, after 24 hours
baseline, after 24 hours
Change in pupillary reflex
Time Frame: baseline, after 24 hours
baseline, after 24 hours
Change in intraocular pressure
Time Frame: baseline, after 24 hours
baseline, after 24 hours
Change in accommodation
Time Frame: baseline, after 24 hours
baseline, after 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in blood pressure
Time Frame: on Day 1 before and 24 hours after treatment and within 8 days after treatment day
on Day 1 before and 24 hours after treatment and within 8 days after treatment day
Change from baseline in pulse rate
Time Frame: on Day 1 before and 24 hours after treatment and within 8 days after treatment day
on Day 1 before and 24 hours after treatment and within 8 days after treatment day
Change in 12-lead ECG
Time Frame: on Day 1 before and 24 hours after treatment and within 8 days after treatment day
on Day 1 before and 24 hours after treatment and within 8 days after treatment day
Changes from baseline in standard laboratory examinations
Time Frame: Baseline and within 8 days after treatment day
Baseline and within 8 days after treatment day
Occurrence of Adverse Events
Time Frame: until 8 days after treatment day
until 8 days after treatment day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 1998

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 1998

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 205.138

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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