Effect of Oral Isotretinoin on Ocular Surface and Meibomian Glands
Assessment of the Effect of Oral Isotretinoin for Acne Treatment on the Ocular Surface and the Morphology of the Meibomian Gland
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedFirst Submitted
Initial submission to the registry
August 1, 2026
CompletedFirst Posted
Study publicly available on registry
August 10, 2026
CompletedAugust 10, 2026
August 1, 2026
1 year
August 1, 2026
August 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
1 Meibomian Gland Morphology (Meiboscore)
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%).
Baseline and 6 months
2 Ocular Surface Disease Index (OSDI) Score
Change in the OSDI questionnaire score (0-100) to assess subjective ocular surface symptoms.
Baseline and 6 months.
Secondary Outcomes (6)
Invasive Tear Film Break-Up Time (ITF-BUT)
Baseline and 6 months.
Schirmer II Test
Baseline and 6 months
5 Ocular Surface Staining (Oxford Scale)
Baseline and 6 months.
6 Meibum Expressibility Score (MES)
Baseline and 6 months.
7 Eyelid Score
Baseline and 6 months.
- +1 more secondary outcomes
Study Arms (2)
Group A
ACTIVE COMPARATORLow-dose oral isotretinoin therapy for patients with clinically diagnosed acne vulgaris.
Group B
NO INTERVENTIONAge- and gender-matched healthy participants without acne vulgaris.
Interventions
1. Meibomian Gland Morphology (Meiboscore) 2. Ocular Surface Disease Index (OSDI) Score 3. Invasive Tear Film Break-Up Time (ITF-BUT) 4. Schirmer II Test 5. Ocular Surface Staining (Oxford Scale) 6. Meibum Expressibility Score (MES) 7. Eyelid Score 8. Non-Invasive Tear Film Break-Up Time (NIF-BUT) time frame: at baseline and 6 months after isotretinoin therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (1)
faculty of Medicine
Banhā, 13518, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 1, 2026
First Posted
August 10, 2026
Study Start
January 1, 2024
Primary Completion
January 1, 2025
Study Completion
June 30, 2025
Last Updated
August 10, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be available beginning 6 months and ending 36 months following the official publication of the study results.
What IPD will be shared? De-identified individual participant data that underlie the results reported in the final study, including demographic characteristics and ocular surface/meibomian gland assessment parameters. Supporting Documents: The study protocol and statistical analysis plan will be made available. When will data be available? Data will be available beginning 6 months and ending 36 months following the official publication of the study results. With whom? Data will be shared with qualified researchers who provide a methodologically sound proposal that is approved by the study investigators. For what types of analyses? To achieve the specific aims outlined in the approved research proposal. By what mechanism will data be made available? Interested researchers should contact the corresponding author via email to submit a formal request and a data use agreement.