Dry EyeNCT05248698
Dry Eye Response to Interval Exercise and Mediterranean Diet
A study testing lifestyle change and exercise in people with Dry Eye and Diet Habit, run by Cairo University at 1 site in Egypt.
Trial summary
in the recent times, dry eye was found to be correlated sedentary life style, obesity, hypertension. So, changing the sedentary lifestyle is recommended Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Dry Eye, Diet Habit, Physical Inactivity
- What is being tested?
- lifestyle change and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2022to 30 Dec 2022
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- elderly patients with dry eye complaints
- the patients will be obese and hypertensives
Who cannot join
- heart or respiration problems
- other diagnosed eye or systemic diseases
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo Unoversity
Giza
Ali Ismail, lecturer, 01005154209, allooka2012@gmail.com
About this study
Official title: Dry Eye Response to Interval Exercise (High Intensity Aerobic Activity) and Mediterranean Diet
in the recent times, dry eye was found to be correlated sedentary life style, obesity, hypertension. So, changing the sedentary lifestyle is recommended
Read the detailed description
older patient who will complain from dry eye will be collected. it is planned to recruit 60 elderly (with obesity and hypertension) to be distributed into group 1 (this group will receive 3-time interval exercise per the week, applied for 30 min with high intensity, plus Mediterranean Diet) and group 2 (this group will receive only 3-time interval exercise per the week, applied for 30 min with high intensity). Every group will contain 30 elderly
- Conditions
- Dry Eye, Diet Habit, Physical Inactivity
- Being tested
- lifestyle change, exercise
- Medical subject headings
- Dry Eye Syndromes, Feeding Behavior, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle changeBehavioural
30 older patient who will complain from dry eye will receive 3-time interval exercise per the week, applied for 30 min with high intensity, plus Mediterranean Diet for 6 months
exerciseOther
30 older patient who will complain from dry eye will receive 3-time interval exercise per the week, applied for 30 min with high intensity, for 6 months
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | 30 older patient who will complain from dry eye will receive 3-time interval exercise per the week, applied for 30 min with high intensity, plus Mediterranean Diet for 6 months Receives: Behavioral: lifestyle change |
| group 2 | Active comparator | 30 older patient who will complain from dry eye will receive 3-time interval exercise per the week, applied for 30 min with high intensity, for 6 months Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer's test
tear-production speed test
Measured: 6 months
Secondary outcomes (9)
scoring system for dry eye
it is a questionnaire will assess dry-eye severity
Measured: 6 months
Ocular surface disability index
it is a questionnaire will assess complaints of patients due to severity of dry-eye
Measured: 6 months
tear film break up time testing
it is a test that will assess tear film stabilization
Measured: 6 months
Oxford grading system
a test will examine ocular epithelial damage
Measured: 6 months
blood systole
it will be measured by sphygmomanometer
Measured: 6 months
blood diastole
it will be measured by sphygmomanometer
Measured: 6 months
weight
it will be expressed in kilograms
Measured: 6 months
body mass index
it will be gained by dividing weight of subject on his or her squared height
Measured: 6 months
waist circumference
it will be evaluated by tape measurements of treatment
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 posted21 Feb 2022
- Study start5 Jan 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248698
- Sponsor's protocol ID
- P.T.REC/012/003553
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Eye Response to Interval Exercise (High Intensity Aerobic Activity) and Mediterranean Diet
- ClinicalTrials.gov ID
- NCT05248698
- Acronym / sponsor ID
- P.T.REC/012/003553
- Conditions
- Dry Eye, Diet Habit, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 21 Feb 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.
in the recent times, dry eye was found to be correlated sedentary life style, obesity, hypertension. So, changing the sedentary lifestyle is recommended
Detailed description
older patient who will complain from dry eye will be collected. it is planned to recruit 60 elderly (with obesity and hypertension) to be distributed into group 1 (this group will receive 3-time interval exercise per the week, applied for 30 min with high intensity, plus Mediterranean Diet) and group 2 (this group will receive only 3-time interval exercise per the week, applied for 30 min with high intensity). Every group will contain 30 elderly
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Behavioral: lifestyle change30 older patient who will complain from dry eye will receive 3-time interval exercise per the week, applied for 30 min with high intensity, plus Mediterranean Diet for 6 months |
| group 2 | Active comparator | Other: exercise30 older patient who will complain from dry eye will receive 3-time interval exercise per the week, applied for 30 min with high intensity, for 6 months |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- elderly patients with dry eye complaints
- the patients will be obese and hypertensives
Key exclusion criteria (2 listed)
- heart or respiration problems
- other diagnosed eye or 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 |
|---|---|---|
| lifestyle change30 older patient who will complain from dry eye will receive 3-time interval exercise per the week, applied for 30 min with high intensity, plus Mediterranean Diet for 6 months | Behavioural | group 1 |
| exercise30 older patient who will complain from dry eye will receive 3-time interval exercise per the week, applied for 30 min with high intensity, for 6 months | Other | group 2 |
Primary outcome
Schirmer's test
Time frame: 6 months
tear-production speed test
9 secondary outcomes
scoring system for dry eye
Time frame: 6 months
Ocular surface disability index
Time frame: 6 months
tear film break up time testing
Time frame: 6 months
Oxford grading system
Time frame: 6 months
blood systole
Time frame: 6 months
blood diastole
Time frame: 6 months
weight
Time frame: 6 months
body mass index
Time frame: 6 months
waist circumference
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
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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.
Ali Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle change and exercise in people with Dry Eye and Diet Habit, run by Cairo 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 2 inclusion and 2 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 21 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Ismail, lecturer (02 01005154209, allooka2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schirmer's test (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 21 Feb 2022; AzTrials last refreshed its copy on 31 Oct 2026.