DrynessNCT05598437
Prevalence of Different Etiologies of Ocular Dryness in Patients Previously Diagnosed With Dry Eye Disease in A Sample of Egyptian Patients
An observational study of Dryness and Dry Eye Syndromes, run by Roweis adel youssef at 2 sites in Egypt.
Trial summary
Proposed Study Title: Prevalence of Different Etiologies of Ocular Dryness in Patients Previously Diagnosed with Dry Eye Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dryness, Dry Eye Syndromes, Meibomian Gland Dysfunction
- What is being tested?
- Dry eye device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2022to 30 Apr 2023
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Egyptian people between 20 and 70 years old coming to outpatient clinic BUT< 10 seconds.. No previous surgery. No previous trauma. Not using eye drops in the last 3 months.
Who may be able to join
- Egyptian people between 20 and 70 years old coming to outpatient clinic BUT< 10 seconds.. No previous surgery. No previous trauma. Not using eye drops in the last 3 months.
Who cannot join
- Diabetic patients. Patients with rheumatological diseases that may affect ocular surface as RA.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Cairo university
Giza, 4332
Roweis Adel, +21200797626, rowaisadel1992@gmail.com
Dr mohamed Hosny, Md
- Recruiting
Cairo university
Giza, 5243
Roweis Adel, Master, 01554558081
Mohamed Hosny, Md
About this study
Official title: Search Protocol 1. Study a-Proposed Study Title: Prevalence of Different Etiologies of Ocular Dryness in Patients Previously Diagnosed With Dry Eye Disease in A Sample of Egyptian Patients
Proposed Study Title: Prevalence of Different Etiologies of Ocular Dryness in Patients Previously Diagnosed with Dry Eye
Read the detailed description
Dry eye disease (DED) is a common chronic multifactorial condition of the ocular surface characterized by failure to produce high quality or sufficient amounts of tears to moisturize the eyes (1) DED can be categorized as "dry eye with reduced tear production (aqueous deficient) and dry eye with increased evaporation of the tear film known as the hyperevaporative type… Although 10% of individuals have aqueous deficient DED, more than 80% have either the hyperevaporative type related to meibomian gland dysfunction (MGD), or a combination of
- Conditions
- Dryness, Dry Eye Syndromes, Meibomian Gland Dysfunction
- Being tested
- Dry eye device
- Keywords
- Dry eye disease
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry eye deviceDevice
Dry eye analysis
| Study group | Role | What they receive |
|---|---|---|
| A | Left eye Receives: Device: Dry eye device | |
| B | Right eye Receives: Device: Dry eye device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibomian gland dysfunction
Meibomian gland dysfunction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DrynessStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roweis adel youssef
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Roweis adel youssef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598437
- Sponsor's protocol ID
- 1298756727278
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Study will be in6 months
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search Protocol 1. Study a-Proposed Study Title: Prevalence of Different Etiologies of Ocular Dryness in Patients Previously Diagnosed With Dry Eye Disease in A Sample of Egyptian Patients
- ClinicalTrials.gov ID
- NCT05598437
- Acronym / sponsor ID
- 1298756727278
- Conditions
- Dryness, Dry Eye Syndromes, Meibomian Gland Dysfunction
- Keywords
- Dry eye disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Roweis adel youssefUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 28 Oct 2022 (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.
Proposed Study Title: Prevalence of Different Etiologies of Ocular Dryness in Patients Previously Diagnosed with Dry Eye
Detailed description
Dry eye disease (DED) is a common chronic multifactorial condition of the ocular surface characterized by failure to produce high quality or sufficient amounts of tears to moisturize the eyes (1) DED can be categorized as "dry eye with reduced tear production (aqueous deficient) and dry eye with increased evaporation of the tear film known as the hyperevaporative type… Although 10% of individuals have aqueous deficient DED, more than 80% have either the hyperevaporative type related to meibomian gland dysfunction (MGD), or a combination of
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: Dry eye deviceLeft eye |
| B | – | Device: Dry eye deviceRight eye |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Egyptian people between 20 and 70 years old coming to outpatient clinic BUT< 10 seconds.. No previous surgery. No previous trauma. Not using eye drops in the last 3 months.
Key inclusion criteria (1 listed)
- Egyptian people between 20 and 70 years old coming to outpatient clinic BUT< 10 seconds.. No previous surgery. No previous trauma. Not using eye drops in the last 3 months.
Key exclusion criteria (1 listed)
- Diabetic patients. Patients with rheumatological diseases that may affect ocular surface as RA.
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 |
|---|---|---|
| Dry eye deviceDry eye analysis | Device | A, B |
Primary outcome
Meibomian gland dysfunction
Time frame: 6 months
Meibomian gland dysfunction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: Undecided. Study will be in6 months
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dryness and Dry Eye Syndromes, run by Roweis adel youssef at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roweis Adel (+21200797626, rowaisadel1992@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meibomian gland dysfunction (time frame: 6 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 28 Oct 2022.