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NCT Number: NCT07753811

Effect of Oral Isotretinoin on Ocular Surface and Meibomian Glands

The aim of the study was to evaluate meibomian gland morphology using non-contact meibography and ocular surface changes in patients with acne vulgaris treated with isotretinoin as indicators of dry eye, which is known to be a side effect of isotretinoin.

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Key information

About this study

Purpose: This study investigated the effects of oral isotretinoin treatment for acne vulgaris on the ocular surface and meibomian gland morphology. Isotretinoin, a common and effective acne medication, is known to cause dry eye symptoms, but its specific impact on ocular surface parameters and meibomian glands requires further detailed assessment.

Study Design: This was a prospective, non-randomized, controlled study involving 60 participants. Thirty patients with moderate to severe acne vulgaris, who were candidates for oral isotretinoin therapy, were recruited as the case group. A control group of 30 age- and gender-matched healthy individuals without acne vulgaris was also included. The case group received low-dose oral isotretinoin (0.1-0.4 mg/kg/day) for 6 months, while the control group received no intervention.

Outcome Measures: Primary outcome measures included changes in Meibomian gland Morphology (assessed by Meiboscore via non-contact meibography) and Ocular Surface Disease Index (OSDI) scores. Secondary outcome measures included changes in Invasive Tear Film Break-Up Time (ITF-BUT), Schirmer II test results, Ocular Surface Staining (Oxford Scale), Meibum Expressibility Score (MES), Eyelid Score, and Non-Invasive Tear Film Break-Up Time (NIF-BUT). All ocular parameters were assessed at baseline and after 6 months of treatment in the case group and at baseline in the control group.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with clinically diagnosed acne vulgaris with various degrees of severity candidates for oral isotretinoin treatment.
  • Moderate to advanced stage of acne vulgaris.
  • No significant improvement with local and systemic antibiotic therapy.
  • Normal liver transaminase (AST, ALT) and lipid (Cholesterol, TG) levels

Exclusion criteria

  • Patients with only comedonal acne.
  • Prior use of systemic isotretinoin.
  • Contact lens wearers.
  • History of ocular trauma or surgery (within 1 year).
  • Other systemic or dermatologic diseases.
  • Active conjunctivitis or allergy.
  • Use of medications affecting the ocular surface or meibomian glands. Lid deformity or abnormal lid movement

Treatment and study plan

isotretinoin

Drug
  • Meibomian Gland Morphology (Meiboscore)
  • Ocular Surface Disease Index (OSDI) Score
  • Invasive Tear Film Break-Up Time (ITF-BUT)
  • Schirmer II Test
  • Ocular Surface Staining (Oxford Scale)
  • Meibum Expressibility Score (MES)
  • Eyelid Score
  • Non-Invasive Tear Film Break-Up Time (NIF-BUT) time frame: at baseline and 6 months after isotretinoin therapy

Primary outcomes

  1. 1 Meibomian Gland Morphology (Meiboscore)

    Time frame: Baseline and 6 months

    Change in Meibomian Gland dropout area semi-automatically calculated by percentage and graded as Meiboscore: Grade 0 (no loss), Grade 1 (≤25%), Grade 2 (26-50%), Grade 3 (51-75%), and Grade 4 (>75%).

  2. 2 Ocular Surface Disease Index (OSDI) Score

    Time frame: Baseline and 6 months.

    Change in the OSDI questionnaire score (0-100) to assess subjective ocular surface symptoms.

Secondary outcomes

  1. Invasive Tear Film Break-Up Time (ITF-BUT)

    Time frame: Baseline and 6 months.

    Change in tear film stability measured in seconds after fluorescein instillation.

  2. Schirmer II Test

    Time frame: Baseline and 6 months

    Change in basal tear film production measured in millimeters (mm) with anesthesia.

  3. 5 Ocular Surface Staining (Oxford Scale)

    Time frame: Baseline and 6 months.

    Change in corneal and conjunctival staining evaluated using the Oxford grading schema (Score 0-15).

  4. 6 Meibum Expressibility Score (MES)

    Time frame: Baseline and 6 months.

    Change in meibum expressibility graded from 0 (all glands expressible) to 3 (no glands expressible).

  5. 7 Eyelid Score

    Time frame: Baseline and 6 months.

    Change in eyelid margin signs (telangiectasia, irregularity, obstructed orifices, junction displacement) scored from 0 to 4.

  6. 8 Non-Invasive Tear Film Break-Up Time (NIF-BUT)

    Time frame: Baseline and 6 months

    Change in tear film stability measured non-invasively using the Sirius device.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Assessment of the Effect of Oral Isotretinoin for Acne Treatment on the Ocular Surface and the Morphology of the Meibomian Gland

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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