EpiphoraPhase 2/3CSA-epiphoraNCT04637633
Topical Cyclosporine-A for Management of Epiphora
A Phase 2/3 study testing topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose, in people with Epiphora, run by Farwaniya Hospital at 1 site in Kuwait.
Trial summary
to investigate the clinical outcomes and tolerances of Cyclosporine A (CsA) in treating epiphora in eyes with acquired punctum stenosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiphora
- What is being tested?
- topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteKuwait
- Study dates
- 15 Aug 2020to 1 Nov 2020
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of either sex
- had a diagnosis of epiphora that persisted more than three months both indoors and outdoors
- grade 0 punctal stenosis
- did not adequately respond to artificial tears, topical corticosteroids and topical antibiotics or in whom corticosteroids were discontinued due to their side effects.
Who cannot join
- congenital punctal obstruction
- edematous puncti
- allergic conjunctivitis
- history of dacryocystitis,
- inflammatory systemic diseases
- any previous chemotherapy treatment, and local irradiation.
Show all 10Show fewer
- other causes of epiphora, lid laxity, entropion, and ectropion
- lid malposition, canalicular or nasolacrimal sac or duct obstruction
- previous eyelid or lacrimal drainage surgery
- untreated conjunctivitis or blepharitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Cyclosporine-A for Management of Epiphora in Eyes With Acquired Punctal Stenosis
to investigate the clinical outcomes and tolerances of Cyclosporine A (CsA) in treating epiphora in eyes with acquired punctum stenosis
Read the detailed description
a prospective study included patients who were referred to our outpatient clinics in Farwanyia hospital, Kuwait during the period between July 2019 and January 2020, having symptomatic epiphora associated with severe acquired lower punctal stenosis. Patients were treated with topical 0.05% CsA on twice daily dose with topical preservative free artificial tears Q.I. D. Patients were followed up monthly for at least 3 months by epiphora grading, Fluorescein dye disappearance test (FDT) and evaluating the patient satisfaction
- Conditions
- Epiphora
- Being tested
- topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,
- Keywords
- cyclosporine A, Epiphora, punctal stenosis
- Medical subject headings
- Lacrimal Apparatus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,Drug
Also called preservative free artificial tears
topical preservative free artificial tears Q.I. D.
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine A | Experimental | All patients were treated with topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California) on twice daily dose, in addition to the topical preservative free artificial tears Q.I. D. Receives: Drug: topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epiphora grading
Munk grading system score from 0 to 5 the higher the worse
Measured: 3 months
Secondary outcomes (1)
Fluorescein dye disappearance test (FDT)
via installing a drop of 2% fluorescein and asses the height of the tear film in millimeters
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start15 Aug 2020
- Primary completion30 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpiphoraStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farwaniya Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mona A Nassief, Farwaniya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637633
- Sponsor's protocol ID
- Farwanyia Hospital
- Acronym
- CSA-epiphora
- Status last verified
- Nov 2020
- First submitted
- 29 Jul 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Cyclosporine-A for Management of Epiphora in Eyes With Acquired Punctal Stenosis
- ClinicalTrials.gov ID
- NCT04637633
- Acronym / sponsor ID
- CSA-epiphora / Farwanyia Hospital
- Conditions
- Epiphora
- Keywords
- cyclosporine A, Epiphora, punctal stenosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Farwaniya HospitalOther government
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 20 Nov 2020 (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.
to investigate the clinical outcomes and tolerances of Cyclosporine A (CsA) in treating epiphora in eyes with acquired punctum stenosis
Detailed description
a prospective study included patients who were referred to our outpatient clinics in Farwanyia hospital, Kuwait during the period between July 2019 and January 2020, having symptomatic epiphora associated with severe acquired lower punctal stenosis. Patients were treated with topical 0.05% CsA on twice daily dose with topical preservative free artificial tears Q.I. D. Patients were followed up monthly for at least 3 months by epiphora grading, Fluorescein dye disappearance test (FDT) and evaluating the patient satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine A | Experimental | Drug: topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,All patients were treated with topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California) on twice daily dose, in addition to the topical preservative free artificial tears Q.I. D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients of either sex
- had a diagnosis of epiphora that persisted more than three months both indoors and outdoors
- grade 0 punctal stenosis
- did not adequately respond to artificial tears, topical corticosteroids and topical antibiotics or in whom corticosteroids were discontinued due to their side effects.
Key exclusion criteria (10 listed)
- congenital punctal obstruction
- edematous puncti
- allergic conjunctivitis
- history of dacryocystitis,
- inflammatory systemic diseases
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 |
|---|---|---|
| topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,Also: preservative free artificial tearstopical preservative free artificial tears Q.I. D. | Drug | Cyclosporine A |
Primary outcome
Epiphora grading
Time frame: 3 months
Munk grading system score from 0 to 5 the higher the worse
1 secondary outcome
Fluorescein dye disappearance test (FDT)
Time frame: 3 months
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 23 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Epiphora
RecruitingPhase 2
Low-Dose Atropine Eye Drops for Excessive Tearing (Epiphora)
Epiphora
Not yet recruiting
Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction.
Nasolacrimal Duct Obstruction, Epiphora
Active, not recruiting
Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
Pregnancy, Childbirth
Enrolling by invitationPhase 1
Pain Biomarker Study
Migraine, Cluster Headache
Active, not recruitingPhase 4
A Comparative Analysis of the Effectiveness of Nepafenac Combined With a Lubricant Versus a Lubricant Alone in the Treatment of Epiphora Associated With Lacrimal Punctum Stenosis
Epiphora, Punctal Stenosis
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 2/3 study testing topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose, in people with Epiphora, run by Farwaniya Hospital at 1 site in Kuwait.
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 4 inclusion and 10 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 23 Nov 2020. 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 Kuwait. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Epiphora grading (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2020.