Polycystic Ovary SyndromeNCT07366944
PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes
A study testing exercise and limiting diet and diet limitation in people with Polycystic Ovary Syndrome and Dry Eye, run by Cairo University at 1 site in Egypt.
Trial summary
Women with polycystic ovarian syndrome (PCOS) may complain dryness of their eyes especially obese ones. lifestye changes are main treatrment fro both problems Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Dry Eye, Obesity
- What is being tested?
- exercise and limiting diet and diet limitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2025to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS women
- obese class I
- bilateral dryness of eye
Who cannot join
- liver disoease
- cardiac disease
- renal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza, Dokki
ali ismail, lecturer, 02 01005154209, ali.mohamed@pt.cu.edu.eg
About this study
Official title: PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes in Obese Women
Women with polycystic ovarian syndrome (PCOS) may complain dryness of their eyes especially obese ones. lifestye changes are main treatrment fro both problems
Read the detailed description
Forty females with PCOS, eye dryness , and obesity will asigned to group I or Group II, n=20 for each group. Both groups will receive metformin thrice times daily and low calorie diet for 12 weeks. Group I, additionally will perform one hour of treadmill walking thrice weekly for 12 weeks.
- Conditions
- Polycystic Ovary Syndrome, Dry Eye, Obesity
- Being tested
- exercise and limiting diet, diet limitation
- Medical subject headings
- Polycystic Ovary Syndrome, Dry Eye Syndromes, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise and limiting dietBehavioural
twenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks. Group I, additionally will perform one hour of treadmill walking thrice weekly for 12 weeks.
diet limitationBehavioural
twenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| group number 1 | Experimental | twenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks. Group I, additionally will perform one hour of treadmill walking thrice weekly for 12 weeks. Receives: Behavioral: exercise and limiting diet |
| group number 2 | Active comparator | Twenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks. Receives: Behavioral: diet limitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
schrimer test
it is a test for assessment dye dryness
Measured: it will be measured after 12 weeks
Secondary outcomes (9)
Ocular surface disability index
it is a questionaire for assessment dye dryness
Measured: It will be measured after 12 weeks
dry eye scoring system
it is a questionaire for assessment dye dryness
Measured: It will be measured after 12 weeks
Tear film break-up time
it is a test for assessment dye dryness
Measured: It will be measured after 12 weeks
body mass index
it will be assessed on empty stomach and bowel
Measured: it will be measured after 12 weeks
wasit hip ratio
it will be assessed by dividing wasit circuference on hip circumference
Measured: It will be measured after 12 weeks
wasit circumference
it will be assessed by tape measure
Measured: It will be measured after 12 weeks
testesterone
it will be assessed in serum
Measured: It will be measured after 12 weeks
LH:FSH ratio
The LH (Luteinizing Hormone) to FSH (Follicle-Stimulating Hormone) ratio shows the balance between these reproductive hormones
Measured: It will be measured after 12 weeks
dehydroepiandrosterone
it will ne assessed in serum
Measured: It will be measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start5 Dec 2025
- Primary completion5 Jun 2026 (estimated)
- Study completion5 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- 40 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 MA Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366944
- Sponsor's protocol ID
- IRB000-14233-63
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 26 Jan 2026
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes in Obese Women
- ClinicalTrials.gov ID
- NCT07366944
- Acronym / sponsor ID
- IRB000-14233-63
- Conditions
- Polycystic Ovary Syndrome, Dry Eye, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 5 Jun 2026 (estimated)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 26 Jan 2026 (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.
Women with polycystic ovarian syndrome (PCOS) may complain dryness of their eyes especially obese ones. lifestye changes are main treatrment fro both problems
Detailed description
Forty females with PCOS, eye dryness , and obesity will asigned to group I or Group II, n=20 for each group. Both groups will receive metformin thrice times daily and low calorie diet for 12 weeks. Group I, additionally will perform one hour of treadmill walking thrice weekly for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group number 1 | Experimental | Behavioral: exercise and limiting diettwenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks. Group I, additionally will perform one hour of treadmill walking thrice weekly for 12 weeks. |
| group number 2 | Active comparator | Behavioral: diet limitationTwenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- PCOS women
- obese class I
- bilateral dryness of eye
Key exclusion criteria (3 listed)
- liver disoease
- cardiac disease
- renal disease
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 |
|---|---|---|
| exercise and limiting diettwenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks. Group I, additionally will perform one hour of treadmill walking thrice weekly for 12 weeks. | Behavioural | group number 1 |
| diet limitationtwenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks. | Behavioural | group number 2 |
Primary outcome
schrimer test
Time frame: it will be measured after 12 weeks
it is a test for assessment dye dryness
9 secondary outcomes
Ocular surface disability index
Time frame: It will be measured after 12 weeks
dry eye scoring system
Time frame: It will be measured after 12 weeks
Tear film break-up time
Time frame: It will be measured after 12 weeks
body mass index
Time frame: it will be measured after 12 weeks
wasit hip ratio
Time frame: It will be measured after 12 weeks
wasit circumference
Time frame: It will be measured after 12 weeks
testesterone
Time frame: It will be measured after 12 weeks
LH:FSH ratio
Time frame: It will be measured after 12 weeks
dehydroepiandrosterone
Time frame: It will be measured after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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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.
Ali MA 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 exercise and limiting diet and diet limitation in people with Polycystic Ovary Syndrome and Dry Eye, 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 3 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Ismail, lecturer (01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
schrimer test (time frame: it will be measured after 12 weeks). 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 26 Jan 2026.