NCT07366944

Brief Summary

Women with polycystic ovarian syndrome (PCOS) may complain dryness of their eyes especially obese ones. lifestye changes are main treatrment fro both problems

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Dec 2025Jun 2026

Study Start

First participant enrolled

December 5, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 17, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2026

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 17, 2026

Last Update Submit

January 17, 2026

Conditions

Dry EyeObesityPolycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • schrimer test

    it is a test for assessment dye dryness

    it will be measured after 12 weeks

Secondary Outcomes (9)

  • Ocular surface disability index

    It will be measured after 12 weeks

  • dry eye scoring system

    It will be measured after 12 weeks

  • Tear film break-up time

    It will be measured after 12 weeks

  • body mass index

    it will be measured after 12 weeks

  • wasit hip ratio

    It will be measured after 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: diet limitation

Interventions

exercise and limiting dietBEHAVIORAL

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.

group number 1
diet limitationBEHAVIORAL

twenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks.

group number 2

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS women
  • obese class I
  • bilateral dryness of eye

You may not qualify if:

  • liver disoease
  • cardiac disease
  • renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary SyndromeDry Eye SyndromesObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesLacrimal Apparatus DiseasesEye DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

01005154209ali.mohamed@pt.cu.edu.eg

Ali Ismail

CONTACT

01031321109allooka2012@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 26, 2026

Study Start

December 5, 2025

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

June 5, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

EG(1)