NCT03690622

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_4

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

December 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
Last Updated

October 3, 2018

Status Verified

September 1, 2018

Enrollment Period

1 month

First QC Date

September 12, 2018

Last Update Submit

October 1, 2018

Conditions

GlaucomaIntraocular Pressure

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure change

    Taken by aplanation tonometry

    at presentation, 30 minutes, 4 hours and 24 hours after instillation

Study Arms (2)

BSS

SHAM COMPARATOR

Balanced salt solution

Drug: Balanced salt solution

Dexmedetomidine

ACTIVE COMPARATOR

dexmedetomidine (0.0055%)

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Instillation of eyedrops

Dexmedetomidine
Balanced salt solutionDRUG

instillation of eyedrop

BSS

Eligibility Criteria

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

You may qualify if:

  • Patients with healthy eyes and no history of glaucoma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beirut Eye Specialist Hospital

Beirut, 116-5311, Lebanon

Location

Related Publications (6)

  • Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.

    PMID: 24974815BACKGROUND

  • Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.

    PMID: 16488940BACKGROUND

  • Kim NY, Yoo YC, Park H, Choi YD, Kim CY, Bai SJ. The effect of dexmedetomidine on intraocular pressure increase in patients during robot-assisted laparoscopic radical prostatectomy in the steep Trendelenburg position. J Endourol. 2015 Mar;29(3):310-6. doi: 10.1089/end.2014.0381. Epub 2014 Oct 14.

    PMID: 25137430BACKGROUND

  • Zhou C, Zhu Y, Liu Z, Ruan L. The Effects of Intravenous Dexmedetomidine Injections on IOP in General Anesthesia Intubation: A Meta-Analysis. Biomed Res Int. 2017;2017:6186832. doi: 10.1155/2017/6186832. Epub 2017 Feb 2.

    PMID: 28261613BACKGROUND

  • Vartiainen J, MacDonald E, Urtti A, Rouhiainen H, Virtanen R. Dexmedetomidine-induced ocular hypotension in rabbits with normal or elevated intraocular pressures. Invest Ophthalmol Vis Sci. 1992 May;33(6):2019-23.

    PMID: 1349879BACKGROUND

  • Fakhoury H, Abdelmassih Y, El-Khoury S, Amro M, Zaarour K, Cherfan C, Tomey K, Khoueir Z. Effect of Topical Dexmedetomidine (0.0055%) on Intraocular Pressure in Healthy Eyes: A Randomized Controlled Trial. J Curr Glaucoma Pract. 2021 May-Aug;15(2):58-63. doi: 10.5005/jp-journals-10078-1310.

    PMID: 34720494DERIVED

Related Links

MeSH Terms

Conditions

Glaucoma

Interventions

DexmedetomidineHanks Balanced Salt Solution

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
masking for the drop instilled
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomised control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2018

First Posted

October 1, 2018

Study Start

December 1, 2017

Primary Completion

January 1, 2018

Study Completion

April 3, 2018

Last Updated

October 3, 2018

Record last verified: 2018-09

Locations

LE(1)