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Pupillary Response After Glaucoma Medication (pupil)

Primary Purpose

Drug Effect (Glaucoma Drugs)

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Latanoprost
Timolol
Dorzolamide
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Drug Effect (Glaucoma Drugs)

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • ophthalmological diseases
  • systemic disease
  • smoking
  • refractive error >= 6 diopters

Sites / Locations

  • Glostrup University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Latanoprost

Timolol

dorzolamide

Other

Arm Description

solution, 1 drop of 50ug/ml latanoprost, was given to study eye after washout period of 1 week between drugs

solution, 1 drop of 5mg/ml timolol , was given to study eye after washout period of 1 week between drugs

solution, 1 drop of 20 mg/ml dorzolamide, was given to study eye after washout period of 1 week between drugs

no drug given and pupil measurements were performed before and at 30 and 180 min at equivalent hours as drugs measurements

Outcomes

Primary Outcome Measures

pupillary constriction measured as the post-illimination pupillay response (PIPR)
The pupillary diameter 0 to 10 seconds after light stimulation, the diameter is measured relative to the initial dark adapted pupil diameter

Secondary Outcome Measures

Full Information

First Posted
November 14, 2014
Last Updated
August 11, 2015
Sponsor
Glostrup University Hospital, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02522039
Brief Title
Pupillary Response After Glaucoma Medication
Acronym
pupil
Official Title
Effect of Topical Anti-glaucoma Medications on Late Pupillary Light Reflex, as Evaluated by Pupillometry
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Investigation of the effect on the pupillary constriction by latanoprost, dorzolamide,timolol in healthy subjects. The pupillary constriction is compared to no drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Effect (Glaucoma Drugs)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Latanoprost
Arm Type
Experimental
Arm Description
solution, 1 drop of 50ug/ml latanoprost, was given to study eye after washout period of 1 week between drugs
Arm Title
Timolol
Arm Type
Experimental
Arm Description
solution, 1 drop of 5mg/ml timolol , was given to study eye after washout period of 1 week between drugs
Arm Title
dorzolamide
Arm Type
Experimental
Arm Description
solution, 1 drop of 20 mg/ml dorzolamide, was given to study eye after washout period of 1 week between drugs
Arm Title
Other
Arm Type
No Intervention
Arm Description
no drug given and pupil measurements were performed before and at 30 and 180 min at equivalent hours as drugs measurements
Intervention Type
Drug
Intervention Name(s)
Latanoprost
Intervention Description
1 drop of latanoprost was given to study eye after washout period of 1 week between drugs
Intervention Type
Drug
Intervention Name(s)
Timolol
Other Intervention Name(s)
Optimol
Intervention Description
1 drop of timolol was given to study eye after washout period of 1 week between drugs
Intervention Type
Drug
Intervention Name(s)
Dorzolamide
Intervention Description
1 drop of dorzolamide was given to study eye after washout period of 1 week between drugs
Primary Outcome Measure Information:
Title
pupillary constriction measured as the post-illimination pupillay response (PIPR)
Description
The pupillary diameter 0 to 10 seconds after light stimulation, the diameter is measured relative to the initial dark adapted pupil diameter
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy subjects Exclusion Criteria: ophthalmological diseases systemic disease smoking refractive error >= 6 diopters
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Lund-Andersen, Professor
Organizational Affiliation
Head of the project
Official's Role
Study Director
Facility Information:
Facility Name
Glostrup University Hospital
City
Glostrup
ZIP/Postal Code
DK-2600
Country
Denmark

12. IPD Sharing Statement

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Pupillary Response After Glaucoma Medication

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