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

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:
  • Optimol
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

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.

Clinical Trials on Drug Effect (Glaucoma Drugs)

Clinical Trials on Latanoprost

3
Subscribe