Effect of Topical Dexmedetomidine on Intraocular Pressure

October 1, 2018 updated by: Beirut Eye Specialist Hospital

The Effect of Topical Dexmedetomidine (0.0055%) on Intraocular Pressure in Healthy Eyes: a Randomized Controlled Trial

Evaluate the short-term safety and efficacy of dexmedetomidine (0.0055%) drops on intraocular pressure (IOP) in healthy eyes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 4

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

  • Lebanon
      • Beirut, Lebanon, 116-5311
        • Beirut Eye Specialist 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with healthy eyes and no history of glaucoma

Exclusion Criteria:

  • history of glaucoma, IOP > 24mmHg at baseline, abnormal optic nerve on fundus examination, keratoconus, corneal graft, corneal edema or a history of refractive surgery

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: BSS
Balanced salt solution
Drug: Balanced salt solution
instillation of eyedrop
Active Comparator: Dexmedetomidine
dexmedetomidine (0.0055%)
Drug: Dexmedetomidine
Instillation of eyedrops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure change
Time Frame: at presentation, 30 minutes, 4 hours and 24 hours after instillation
Taken by aplanation tonometry
at presentation, 30 minutes, 4 hours and 24 hours after instillation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beirut Eye Specialist Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

December 1, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

April 3, 2018

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

October 3, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeirutEyeSH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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