Prevalence of Different Etiologies of Ocular Dryness in Patients Previously Diagnosed With Dry Eye Disease in A Sample of Egyptian Patients

• Sponsor: Roweis adel youssef (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05598437
• Collaborator: Cairo University (Other)
• Enrollment: 200
• Locations: 2
• Anticipated Duration (Months): 5.9
• Patients Per Site: 100
• Patients Per Site Per Month: 16.9

Study Details

Study Description

Brief Summary

Proposed Study Title: Prevalence of Different Etiologies of Ocular Dryness in Patients Previously Diagnosed with Dry Eye

Condition or Disease	Intervention/Treatment	Phase
Dryness; Dry Eye Syndromes; Meibomian Gland Dysfunction	Device: Dry eye device

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

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• 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
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
A Left eye	Device: Dry eye device; Dry eye analysis
B Right eye	Device: Dry eye device; Dry eye analysis

Outcome Measures

Primary Outcome Measures

1. Meibomian gland dysfunction [6 months]

   Meibomian gland dysfunction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

Diabetic patients. Patients with rheumatological diseases that may affect ocular surface as RA.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo university	Giza		Egypt	4332
2	Cairo university	Giza		Egypt	5243

Sponsors and Collaborators

• Roweis adel youssef
• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roweis adel youssef, Cairo university, Cairo University
• ClinicalTrials.gov Identifier: NCT05598437
• Other Study ID Numbers: 1298756727278
• First Posted: Oct 28, 2022
• Last Update Posted: Oct 28, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Roweis adel youssef, Cairo university, Cairo University: Dry eye disease
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Meibomian Gland Dysfunction

Study Results

No Results Posted as of Oct 28, 2022