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Not yet recruiting NCT06725290

Dry Eye Disease With Isotretinoin ISOTRETINOIN

Observational Acne Vulgaris

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ocular Surface Disease Index (OSDI) questionnaire.
Who it may be relevant to
Registry conditions: Acne Vulgaris. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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

Interventions

  • 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

Primary outcome measures

  • Total ocular surface disease index (OSDI) SCORE [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • Moderate to severe acne on isotretinoin

Exclusion criteria

  • Occular diseases causing dry eye
  • Pregnant females

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06725290 · Dry eye with isotretinoin

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗