Dry Eye Disease (DED)NCT06752278
Efficacy of Pilocarpine As a Secretagogue Versus Artificial Tears for the Treatment of Dry Eye
A study testing Pilocarpine and artificial tears in people with Dry Eye Disease (DED), run by Al-Azhar University at 1 site in Egypt.
Trial summary
Management approaches for dry eye disease (DED) typically start with low-risk, easily accessible, patient-applied therapies like artificial tears for early-stage disease. As the condition worsens, treatment progresses to more advanced therapies for severe forms of DED. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- Pilocarpine and artificial tears
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 20 Dec 2024
- 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
- Patients diagnosed with DED
Who cannot join
- Previous Occular surgery.
- Refuse to particupate.
- Patients with sjogren syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Management approaches for dry eye disease (DED) typically start with low-risk, easily accessible, patient-applied therapies like artificial tears for early-stage disease. As the condition worsens, treatment progresses to more advanced therapies for severe forms of DED. This study aims to compare the effectiveness and safety of pilocarpine as a secretagogue versus artificial tears in the treatment of dry eye disease. Our goal is to provide reliable, high-quality evidence regarding the efficacy of secretagogues, thereby contributing to the development of recommendations that aid clinicians in their decision-making process
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Pilocarpine, artificial tears
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilocarpineDrug
Pilocarpine is a muscarinic agonist
artificial tearsDrug
artificial tears used for the treatment of Dry eye
| Study group | Role | What they receive |
|---|---|---|
| pilocarpine group | Active comparator | Not described Receives: Drug: Pilocarpine |
| artificial tears group | Active comparator | Not described Receives: Drug: artificial tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index
Measured: At the baseline and after 6 weeks
tear film break-up time
Measured: At the baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start1 Oct 2024
- Primary completion1 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Tharwat, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752278
- Sponsor's protocol ID
- Pilocarpine and Dry Eye
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pilocarpine As a Secretagogue Versus Artificial Tears for the Treatment of Dry Eye
- ClinicalTrials.gov ID
- NCT06752278
- Acronym / sponsor ID
- Pilocarpine and Dry Eye
- Conditions
- Dry Eye Disease (DED)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 30 Dec 2024 (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.
Management approaches for dry eye disease (DED) typically start with low-risk, easily accessible, patient-applied therapies like artificial tears for early-stage disease. As the condition worsens, treatment progresses to more advanced therapies for severe forms of DED. This study aims to compare the effectiveness and safety of pilocarpine as a secretagogue versus artificial tears in the treatment of dry eye disease. Our goal is to provide reliable, high-quality evidence regarding the efficacy of secretagogues, thereby contributing to the development of recommendations that aid clinicians in their decision-making process
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pilocarpine group | Active comparator | Drug: Pilocarpine |
| artificial tears group | Active comparator | Drug: artificial tears |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with DED
Key exclusion criteria (3 listed)
- Previous Occular surgery.
- Refuse to particupate.
- Patients with sjogren syndrome
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 |
|---|---|---|
| PilocarpinePilocarpine is a muscarinic agonist | Drug | pilocarpine group |
| artificial tearsartificial tears used for the treatment of Dry eye | Drug | artificial tears group |
Primary outcome
Ocular Surface Disease Index
Time frame: At the baseline and after 6 weeks
tear film break-up time
Time frame: At the baseline and after 6 weeks
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 30 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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 study testing Pilocarpine and artificial tears in people with Dry Eye Disease (DED), run by Al-Azhar 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 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: finished, as of the sponsor's last update on 30 Dec 2024. 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. 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?
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?
Ocular Surface Disease Index (time frame: At the baseline and after 6 weeks). The study lists 2 primary outcomes in all. 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 30 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.