- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02522039
Pupillary Response After Glaucoma Medication (pupil)
August 11, 2015 updated by: Birgit Sander, Glostrup University Hospital, Copenhagen
Effect of Topical Anti-glaucoma Medications on Late Pupillary Light Reflex, as Evaluated by Pupillometry
Investigation of the effect on the pupillary constriction by latanoprost, dorzolamide,timolol in healthy subjects.
The pupillary constriction is compared to no drug.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Glostrup, Denmark, DK-2600
- Glostrup University Hospital
-
-
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
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy subjects
Exclusion Criteria:
- ophthalmological diseases
- systemic disease
- smoking
- refractive error >= 6 diopters
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Latanoprost
solution, 1 drop of 50ug/ml latanoprost, was given to study eye after washout period of 1 week between drugs
|
1 drop of latanoprost was given to study eye after washout period of 1 week between drugs
|
Experimental: Timolol
solution, 1 drop of 5mg/ml timolol , was given to study eye after washout period of 1 week between drugs
|
1 drop of timolol was given to study eye after washout period of 1 week between drugs
Other Names:
|
Experimental: dorzolamide
solution, 1 drop of 20 mg/ml dorzolamide, was given to study eye after washout period of 1 week between drugs
|
1 drop of dorzolamide was given to study eye after washout period of 1 week between drugs
|
No Intervention: Other
no drug given and pupil measurements were performed before and at 30 and 180 min at equivalent hours as drugs measurements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pupillary constriction measured as the post-illimination pupillay response (PIPR)
Time Frame: 1 day
|
The pupillary diameter 0 to 10 seconds after light stimulation, the diameter is measured relative to the initial dark adapted pupil diameter
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Henrik Lund-Andersen, Professor, Head of the project
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
May 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
November 14, 2014
First Submitted That Met QC Criteria
August 11, 2015
First Posted (Estimate)
August 13, 2015
Study Record Updates
Last Update Posted (Estimate)
August 13, 2015
Last Update Submitted That Met QC Criteria
August 11, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Ocular Hypertension
- Glaucoma
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Enzyme Inhibitors
- Carbonic Anhydrase Inhibitors
- Pharmaceutical Solutions
- Ophthalmic Solutions
- Timolol
- Dorzolamide
- Latanoprost
Other Study ID Numbers
- GlostrupUH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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