NCT02522039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

November 14, 2014

Last Update Submit

August 11, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    1 day

Study Arms (4)

Latanoprost

EXPERIMENTAL

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

Drug: Latanoprost

Timolol

EXPERIMENTAL

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

Drug: Timolol

dorzolamide

EXPERIMENTAL

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

Drug: Dorzolamide

Other

NO INTERVENTION

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

Interventions

1 drop of latanoprost was given to study eye after washout period of 1 week between drugs

Latanoprost

1 drop of timolol was given to study eye after washout period of 1 week between drugs

Also known as: Optimol
Timolol

1 drop of dorzolamide was given to study eye after washout period of 1 week between drugs

dorzolamide

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup University Hospital

Glostrup Municipality, DK-2600, Denmark

Location

MeSH Terms

Interventions

LatanoprostTimololdorzolamide

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Study Officials

  • Henrik Lund-Andersen, Professor

    Head of the project

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
md

Study Record Dates

First Submitted

November 14, 2014

First Posted

August 13, 2015

Study Start

May 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations