Epiphora Due to Insufficient DrainagePhase 4NCT04318652
OCT Guided Punctal Stenosis Management
A Phase 4 study testing Methylprednisolone eyedrops in people with Epiphora Due to Insufficient Drainage, run by Tanta University at 1 site in Egypt.
Trial summary
This is a clinical trial study that was conducted on patients with punctal stenosis.We studied the diameter of stenosed puncta before and after treatment with preserved free steroid eye drops using AS-OCT. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epiphora Due to Insufficient Drainage
- What is being tested?
- Methylprednisolone eyedrops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Sep 2018to 20 Sep 2019
- 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 have acquired inflammatory punctum stenosis complaining of epiphora of different etiologies.
Who cannot join
- Previous lacrimal surgery.
- Lid margin malposition such as ectropion, entropion or lid retraction.
- Medial lid masses obscuring punctum.
- History of ocular trauma involving lid margin or punctum.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Anterior Segment Optical Coherence Tomography in Management of Acquired Punctal Stenosis
This is a clinical trial study that was conducted on patients with punctal stenosis.We studied the diameter of stenosed puncta before and after treatment with preserved free steroid eye drops using AS-OCT.
Read the detailed description
The study was conducted on 40 eyes of 24 patients have acquired inflammatory punctal stenosis and 20 eyes of 10 patients of normal asymptomatic subjects as control group. We studied the external punctal diameter, visibility of the internal punctum and punctal depth before treatment using AS-OCT, and then patients were re-evaluated after one month of treatment with preservative free methylprednisolone 5% eye drops.
- Conditions
- Epiphora Due to Insufficient Drainage
- Being tested
- Methylprednisolone eyedrops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone eyedropsDrug
instillation of methylprednisolone eye drops
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone eye drops | Other | Preservative free steroids methylprednisolone 5% eye drops (prepared by dilution of methyleprednisolone 500mg in 10 ml distilled water (Solu-Medrol, Pfizer company) was prepared and given for all enrolled cases by the following regimen 5 times/day for 5 days with gradual decrease every third day over the following 2 weeks Receives: Drug: Methylprednisolone eyedrops |
| distilled water eyedrops | Placebo comparator | Distilled water eyedrops instilled 3 times per day for two weeks Receives: Drug: Methylprednisolone eyedrops |
What is being measured
The primary outcome is the main question the study is designed to answer.
punctal opening
evaluation of punctalopening by OCT
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start2 Sep 2018
- Primary completion5 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiphora Due to Insufficient DrainageStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mahmoud Awara, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318652
- Sponsor's protocol ID
- 32399/09/18
- Status last verified
- Mar 2020
- First submitted
- 15 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Anterior Segment Optical Coherence Tomography in Management of Acquired Punctal Stenosis
- ClinicalTrials.gov ID
- NCT04318652
- Acronym / sponsor ID
- 32399/09/18
- Conditions
- Epiphora Due to Insufficient Drainage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 2 Sep 2018 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 24 Mar 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.
This is a clinical trial study that was conducted on patients with punctal stenosis.We studied the diameter of stenosed puncta before and after treatment with preserved free steroid eye drops using AS-OCT.
Detailed description
The study was conducted on 40 eyes of 24 patients have acquired inflammatory punctal stenosis and 20 eyes of 10 patients of normal asymptomatic subjects as control group. We studied the external punctal diameter, visibility of the internal punctum and punctal depth before treatment using AS-OCT, and then patients were re-evaluated after one month of treatment with preservative free methylprednisolone 5% eye drops.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone eye drops | Other | Drug: Methylprednisolone eyedropsPreservative free steroids methylprednisolone 5% eye drops (prepared by dilution of methyleprednisolone 500mg in 10 ml distilled water (Solu-Medrol, Pfizer company) was prepared and given for all enrolled cases by the following regimen 5 times/day for 5 days with gradual decrease every third day over the following 2 weeks |
| distilled water eyedrops | Placebo comparator | Drug: Methylprednisolone eyedropsDistilled water eyedrops instilled 3 times per day for two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients have acquired inflammatory punctum stenosis complaining of epiphora of different etiologies.
Key exclusion criteria (4 listed)
- Previous lacrimal surgery.
- Lid margin malposition such as ectropion, entropion or lid retraction.
- Medial lid masses obscuring punctum.
- History of ocular trauma involving lid margin or punctum.
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 |
|---|---|---|
| Methylprednisolone eyedropsinstillation of methylprednisolone eye drops | Drug | Methylprednisolone eye drops, distilled water eyedrops |
Primary outcome
punctal opening
Time frame: one month
evaluation of punctalopening by OCT
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 24 Mar 2020.
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 Methylprednisolone eyedrops in people with Epiphora Due to Insufficient Drainage, run by Tanta University at 1 site in Egypt.
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 4 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 24 Mar 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 Egypt. 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?
punctal opening (time frame: one month). 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 24 Mar 2020.