Back to resultsEffect of Topical Dexmedetomidine on Intraocular Pressure
Primary Purpose
Glaucoma, Intraocular Pressure
Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Dexmedetomidine
Balanced salt solution
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
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
Sites / Locations
- Beirut Eye Specialist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
BSS
Dexmedetomidine
Arm Description
Balanced salt solution
dexmedetomidine (0.0055%)
Outcomes
Primary Outcome Measures
Intraocular pressure change
Taken by aplanation tonometry
Secondary Outcome Measures
Full Information
NCT ID
NCT03690622
First Posted
September 12, 2018
Last Updated
October 1, 2018
Sponsor
Beirut Eye Specialist Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03690622
Brief Title
Effect of Topical Dexmedetomidine on Intraocular Pressure
Official Title
The Effect of Topical Dexmedetomidine (0.0055%) on Intraocular Pressure in Healthy Eyes: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
April 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beirut Eye Specialist Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluate the short-term safety and efficacy of dexmedetomidine (0.0055%) drops on intraocular pressure (IOP) in healthy eyes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Intraocular Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomised control trial
Masking
ParticipantInvestigator
Masking Description
masking for the drop instilled
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BSS
Arm Type
Sham Comparator
Arm Description
Balanced salt solution
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
dexmedetomidine (0.0055%)
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Instillation of eyedrops
Intervention Type
Drug
Intervention Name(s)
Balanced salt solution
Intervention Description
instillation of eyedrop
Primary Outcome Measure Information:
Title
Intraocular pressure change
Description
Taken by aplanation tonometry
Time Frame
at presentation, 30 minutes, 4 hours and 24 hours after instillation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Beirut Eye Specialist Hospital
City
Beirut
ZIP/Postal Code
116-5311
Country
Lebanon
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24974815
Citation
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.
Results Reference
background
PubMed Identifier
16488940
Citation
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.
Results Reference
background
PubMed Identifier
25137430
Citation
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.
Results Reference
background
PubMed Identifier
28261613
Citation
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.
Results Reference
background
PubMed Identifier
1349879
Citation
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.
Results Reference
background
PubMed Identifier
34720494
Citation
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.
Results Reference
derived
Links:
URL
http://www.google.com.pg/patents/US8445526
Description
Patent
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Effect of Topical Dexmedetomidine on Intraocular Pressure
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