GlaucomaPhase 4NCT03690622
Effect of Topical Dexmedetomidine on Intraocular Pressure
A Phase 4 study testing Dexmedetomidine and Balanced salt solution in people with Glaucoma and Intraocular Pressure, run by Beirut Eye Specialist Hospital at 1 site in Lebanon.
Trial summary
Evaluate the short-term safety and efficacy of dexmedetomidine (0.0055%) drops on intraocular pressure (IOP) in healthy eyes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Intraocular Pressure
- What is being tested?
- Dexmedetomidine and Balanced salt solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Dec 2017to 3 Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with healthy eyes and no history of glaucoma
Who cannot join
- history of glaucoma, IOP > 24mmHg at baseline, abnormal optic nerve on fundus examination, keratoconus, corneal graft, corneal edema or a history of refractive surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Glaucoma, Intraocular Pressure
- Being tested
- Dexmedetomidine, Balanced salt solution
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Instillation of eyedrops
Balanced salt solutionDrug
instillation of eyedrop
| Study group | Role | What they receive |
|---|---|---|
| BSS | Sham comparator | Balanced salt solution Receives: Drug: Balanced salt solution |
| Dexmedetomidine | Active comparator | dexmedetomidine (0.0055%) Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure change
Taken by aplanation tonometry
Measured: at presentation, 30 minutes, 4 hours and 24 hours after instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Dec 2017
- Primary completion1 Jan 2018
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised control trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beirut Eye Specialist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690622
- Sponsor's protocol ID
- BeirutEyeSH
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24974815Quigley 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.
PubMed 16488940Kim 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.
PubMed 25137430Zhou 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.
PubMed 28261613Vartiainen 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.
PubMed 1349879Fakhoury 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.
PubMed 34720494
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Dexmedetomidine (0.0055%) on Intraocular Pressure in Healthy Eyes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03690622
- Acronym / sponsor ID
- BeirutEyeSH
- Conditions
- Glaucoma, Intraocular Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Beirut Eye Specialist HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the short-term safety and efficacy of dexmedetomidine (0.0055%) drops on intraocular pressure (IOP) in healthy eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomised control trial
| Arm | Type | Receives |
|---|---|---|
| BSS | Sham comparator | Drug: Balanced salt solutionBalanced salt solution |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidinedexmedetomidine (0.0055%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with healthy eyes and no history of glaucoma
Key exclusion criteria (1 listed)
- history of glaucoma, IOP > 24mmHg at baseline, abnormal optic nerve on fundus examination, keratoconus, corneal graft, corneal edema or a history of refractive surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineInstillation of eyedrops | Drug | Dexmedetomidine |
| Balanced salt solutioninstillation of eyedrop | Drug | BSS |
Primary outcome
Intraocular pressure change
Time frame: at presentation, 30 minutes, 4 hours and 24 hours after instillation
Taken by aplanation tonometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Background: PubMed 24974815Tham 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.
- Background: PubMed 16488940Quigley 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.
- Background: PubMed 25137430Kim 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.
- Background: PubMed 28261613Zhou 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.
- Background: PubMed 1349879Vartiainen 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.
- Derived from this study: PubMed 34720494Fakhoury 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.
- PatentLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Balanced salt solution in people with Glaucoma and Intraocular Pressure, run by Beirut Eye Specialist Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure change (time frame: at presentation, 30 minutes, 4 hours and 24 hours after instillation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03690622, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.