NCT04454281

Brief Summary

Chronic ocular neuropathic pain may be misdiagnosed as dry eye disease. Our study aims to identify a population with previous monocular trauma and dry eye symptoms and differentiate neuropathic from dry eye pain using topical corneal naloxone hydrochloride.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

June 24, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2020

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

June 24, 2020

Last Update Submit

November 4, 2022

Conditions

Dry Eye SyndromesNeuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Response to Hypertonic Saline (Muro 128) drop

    The pain response is graded using a Visual Analog Scale (VAS) survey. It is graded 1-10; 10 indicates the most severe pain.

    Immediately after hypertonic drop administered. Measured during both study visits, thus through study completion, an expected average of 4 weeks.

Secondary Outcomes (5)

  • Ocular Surface Disease Index

    At any point during study visit. Measured during both study visits, thus through study completion, an expected average of 4 weeks.

  • Slit Lamp Biomicroscopy

    Before and after hypertonic saline drop. Measured during both study visits, thus through study completion, an expected average of 4 weeks.

  • Flourescein corneal examination

    Before and after hypertonic saline drop. Measured during both study visits, thus through study completion, an expected average of 4 weeks.

  • intraocular pressure

    Before and after hypertonic saline drop. Measured during both study visits, thus through study completion, an expected average of 4 weeks.

  • visual acuity

    Before and after hypertonic saline drop. Measured during both study visits, thus through study completion, an expected average of 4 weeks.

Study Arms (2)

Naloxone HCl Low dose: 0.02 mg

EXPERIMENTAL

This arm will receive 0.02 mg naloxone hcl on the experimental visit and balance salt solution on the control visit.

Drug: Naloxone Hydrochloride 0.4 MG/ML

Naloxone HCl High dose: 0.08 mg

EXPERIMENTAL

This arm will receive 0.08 mg naloxone hcl on the experimental visit and balance salt solution on the control visit.

Drug: Naloxone Hydrochloride 0.4 MG/ML

Interventions

Naloxone Hydrochloride 0.4 MG/MLDRUG

Drug will be topically applied to the corneal surface then study evaluations will ensue.

Naloxone HCl High dose: 0.08 mgNaloxone HCl Low dose: 0.02 mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • monocular trauma
  • dry eye disease diagnosis

You may not qualify if:

  • any pathology that might contribute to ocular pain, including corneal surface ulcers, uveitis, or other chronic inflammatory processes
  • any current corneal surface pathology
  • history of bilateral ocular trauma
  • currently taking any of the following medications: TCAs, opioids, gabapentin, SNRIs
  • pregnant nor breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Dry Eye SyndromesNeuralgia

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Seema Capoor, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor

Study Record Dates

First Submitted

June 24, 2020

First Posted

July 1, 2020

Study Start

October 1, 2020

Primary Completion

December 3, 2020

Study Completion

December 3, 2020

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)