NCT03139708

Brief Summary

This an interventional study looking at two different sequences of pre-operative eye drops, to determine which order is more effective in reducing intraocular pressure with pupil dilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

October 5, 2016

Last Update Submit

August 7, 2018

Conditions

Intraocular Pressure

Keywords

MydriasisCycloplegics

Outcome Measures

Primary Outcomes (1)

  • Change in intraocular pressure from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours.

    Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.

    5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.

Secondary Outcomes (2)

  • Change in pupil size pupil size from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours.

    5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.

  • Change in pupil's reaction to light from baseline to 15 min after last drop given,30 min, 1 hour, and 4 hours.

    5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.

Study Arms (3)

Alphagan plus

EXPERIMENTAL

Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.

Drug: AlphaganDrug: PhenylephrineDrug: Tropicamide

Tropicamide and Phenylephrine plus

EXPERIMENTAL

Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.

Drug: AlphaganDrug: PhenylephrineDrug: Tropicamide

Tropicamide and Phenylephrine only

ACTIVE COMPARATOR

Tropicamide and Phenylephrine only arm is given one drop of each times one.

Drug: PhenylephrineDrug: Tropicamide

Interventions

AlphaganDRUG

Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.

Also known as: Brimonidine
Alphagan plusTropicamide and Phenylephrine plus
PhenylephrineDRUG

Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.

Alphagan plusTropicamide and Phenylephrine onlyTropicamide and Phenylephrine plus
TropicamideDRUG

Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.

Alphagan plusTropicamide and Phenylephrine onlyTropicamide and Phenylephrine plus

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy with no major medical conditions. Contact lens wear is ok but must be not worn on the day of the study

You may not qualify if:

  • Diabetic, history of glaucoma
  • history of iris trauma
  • history of eye surgery except LASIK or Photorefractive keratectomy laser eye surgery
  • Anisocoria
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Health Eye Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Mydriasis

Interventions

Brimonidine TartratePhenylephrineTropicamide

Condition Hierarchy (Ancestors)

Pupil DisordersEye Diseases

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Keith Walter, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The PI measuring pupil size will not know the subject assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2016

First Posted

May 4, 2017

Study Start

September 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations

US(1)