Ocular Penetration of Topical TacrolimusNCT02794610
Ocular Penetration of Topical Tacrolimus Eye Drops
A study testing Tacrolimus in people with Ocular Penetration of Topical Tacrolimus, run by The Eye Center and The Eye Foundation for Research in Ophthalmology at 1 site in Saudi Arabia.
Trial summary
Investigators aim to evaluate the ocular penetration of topical tacrolimus 0.03% eye drops. Topical tacrolimus 0.03% will be instilled into the eyes of patients 15 minutes before cataract surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ocular Penetration of Topical Tacrolimus
- What is being tested?
- Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- May 2016to Jul 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any age or gender
- Patients scheduled for routine cataract surgery
- Clear healthy cornea
Who cannot join
- Corneal pathology
- Ocular surface disease
- Intraocular inflammation
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
The Eye Center
Riyadh, 11534
Samir S Shoughy, MD, +966 11 464 9614 ext. 222, samir.shawki@hotmail.com
About this study
Investigators aim to evaluate the ocular penetration of topical tacrolimus 0.03% eye drops.
Topical tacrolimus 0.03% will be instilled into the eyes of patients 15 minutes before cataract surgery. Aqueous samples will be collected at the time of cataract surgery and will be subjected to detection of presence and level of tacrolimus.
- Conditions
- Ocular Penetration of Topical Tacrolimus
- Being tested
- Tacrolimus
- Keywords
- Tacrolimus, Ocular penetration, Topical
- Medical subject headings
- Eye Injuries, Penetrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Topical tacrolimus 0.05% eye drops will be instilled into the eyes of patients every minute for 5 minutes. After 15 minutes, at the time of cataract surgery, aqueous samples will be collected and will be subjected to detection of presence and level of tacrolimus.
| Study group | Role | What they receive |
|---|---|---|
| Topical tacrolimus | Experimental | Ten patients will be include. Topical tacrolimus 0.05% will be instilled into the eyes of patients 15 minutes before cataract surgery. Aqueous samples will be collected at the time of cataract surgery and will be subjected to detection of presence and level of tacrolimus. Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of the concentration of tacrolimus ( nanograms/milliliter) in the anterior chamber following ocular topical application.
Measured: From date of obtaining the aqueous samples until getting the laboratory results of concentration of topical tacrolimus in the aqueous humor up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ocular Penetration of Topical TacrolimusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Eye Center and The Eye Foundation for Research in Ophthalmology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794610
- Sponsor's protocol ID
- 2015-01(P)
- Status last verified
- May 2016
- First submitted
- 26 May 2016
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Shoughy SS, Aljassar FM, Tabbara KF. Aqueous penetration of topical tacrolimus. Am J Ophthalmol Case Rep. 2020 Jan 17;17:100582. doi: 10.1016/j.ajoc.2019.100582. eCollection 2020 Mar.
PubMed 32025589
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Penetration of Topical Tacrolimus Eye Drops
- ClinicalTrials.gov ID
- NCT02794610
- Acronym / sponsor ID
- 2015-01(P)
- Conditions
- Ocular Penetration of Topical Tacrolimus
- Keywords
- Tacrolimus, Ocular penetration, Topical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Eye Center and The Eye Foundation for Research in OphthalmologyUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 9 Jun 2016 (estimated)
- 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.
Investigators aim to evaluate the ocular penetration of topical tacrolimus 0.03% eye drops.
Topical tacrolimus 0.03% will be instilled into the eyes of patients 15 minutes before cataract surgery. Aqueous samples will be collected at the time of cataract surgery and will be subjected to detection of presence and level of tacrolimus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical tacrolimus | Experimental | Drug: TacrolimusTen patients will be include. Topical tacrolimus 0.05% will be instilled into the eyes of patients 15 minutes before cataract surgery. Aqueous samples will be collected at the time of cataract surgery and will be subjected to detection of presence and level of tacrolimus. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Any age or gender
- Patients scheduled for routine cataract surgery
- Clear healthy cornea
Key exclusion criteria (3 listed)
- Corneal pathology
- Ocular surface disease
- Intraocular inflammation
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 |
|---|---|---|
| TacrolimusTopical tacrolimus 0.05% eye drops will be instilled into the eyes of patients every minute for 5 minutes. After 15 minutes, at the time of cataract surgery, aqueous samples will be collected and will be subjected to detection of presence and level of tacrolimus. | Drug | Topical tacrolimus |
Primary outcome
Detection of the concentration of tacrolimus ( nanograms/milliliter) in the anterior chamber following ocular topical application.
Time frame: From date of obtaining the aqueous samples until getting the laboratory results of concentration of topical tacrolimus in the aqueous humor up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Derived from this study: PubMed 32025589Shoughy SS, Aljassar FM, Tabbara KF. Aqueous penetration of topical tacrolimus. Am J Ophthalmol Case Rep. 2020 Jan 17;17:100582. doi: 10.1016/j.ajoc.2019.100582. eCollection 2020 Mar.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tacrolimus in people with Ocular Penetration of Topical Tacrolimus, run by The Eye Center and The Eye Foundation for Research in Ophthalmology at 1 site in Saudi Arabia.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jun 2016. 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 Saudi Arabia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ssmir S Shoughy, MD (+966 11 464 9614 ext. 222, samir.shawki@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of the concentration of tacrolimus ( nanograms/milliliter) in the anterior chamber following ocular topical application. (time frame: From date of obtaining the aqueous samples until getting the laboratory results of concentration of topical tacrolimus in the aqueous humor up to 2 months). 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 NCT02794610, which also lists 1 linked publication.
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 9 Jun 2016.