Dry Eye Disease With Isotretinoin ISOTRETINOIN

May 10, 2025 updated by: Hagar El Sayed, Cairo University

Digital Assessment of Dry Eye Diseases in Acne Vulgaris Patients Receiving Isotretinoin Therapy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Acne patients on isotretinoin

Description

Inclusion Criteria:

  • Moderate to severe acne on isotretinoin

Exclusion Criteria:

  • Occular diseases causing dry eye
  • Pregnant females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal control
Diagnostic test: 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
low dose isotretinoin
Acne patients taking 20 mg daily isotretinoin
Diagnostic test: 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
high dose isotretinoin
Acne patients taking 0.5 mg/kg daily dose of isotretinoin
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total ocular surface disease index (OSDI) SCORE
Time Frame: 3 months
Total OSDI score ranged from 0 to 100 with means greater symptom severity
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

December 8, 2024

First Submitted That Met QC Criteria

December 8, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 10, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dry eye with isotretinoin

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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