Dry Eye Disease With Isotretinoin ISOTRETINOIN

NCT ID: NCT06725290

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-09-30

Brief Summary

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The study aims to explore the effects of isotretinoin therapy on the dry eye parameters in acne vulgaris patients \& determine if it is dose-dependent or not.

Detailed Description

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To measure the tear film, the eye lid thickness, the meibomian gland function and to do objective tests for comparison

Conditions

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Acne Vulgaris

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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low dose isotretinoin

Acne patients taking 20 mg daily isotretinoin

Ocular Surface Disease Index (OSDI) questionnaire

Intervention Type DIAGNOSTIC_TEST

The OSDI is a validated, self-administered questionnaire for assessing the presence and severity of ocular surface disease symptoms. The OSDI questionnaire includes 12 questions about the respondent's past week experience with the ocular symptoms, vision-related function, and environmental triggers

high dose isotretinoin

Acne patients taking 0.5 mg/kg daily dose of isotretinoin

Ocular Surface Disease Index (OSDI) questionnaire

Intervention Type DIAGNOSTIC_TEST

The OSDI is a validated, self-administered questionnaire for assessing the presence and severity of ocular surface disease symptoms. The OSDI questionnaire includes 12 questions about the respondent's past week experience with the ocular symptoms, vision-related function, and environmental triggers

Normal control

Ocular Surface Disease Index (OSDI) questionnaire

Intervention Type DIAGNOSTIC_TEST

The OSDI is a validated, self-administered questionnaire for assessing the presence and severity of ocular surface disease symptoms. The OSDI questionnaire includes 12 questions about the respondent's past week experience with the ocular symptoms, vision-related function, and environmental triggers

Interventions

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Ocular Surface Disease Index (OSDI) questionnaire

The OSDI is a validated, self-administered questionnaire for assessing the presence and severity of ocular surface disease symptoms. The OSDI questionnaire includes 12 questions about the respondent's past week experience with the ocular symptoms, vision-related function, and environmental triggers

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe acne on isotretinoin

Exclusion Criteria

* Occular diseases causing dry eye
* Pregnant females
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hagar El Sayed

University doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Dry eye with isotretinoin

Identifier Type: -

Identifier Source: org_study_id

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