An interventional study of isotretinoin in Dry Eye Disease (DED), Meibomian Gland Dysfunction (Disorder) and Acne Vulgaris, sponsored by Benha University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Benha University · Not applicable, Interventional, and Health services research
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.
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low-dose oral isotretinoin therapy for patients with clinically diagnosed acne vulgaris.
Drug: isotretinoin
Age- and gender-matched healthy participants without acne vulgaris.
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
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%).
Time frame: 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.
Time frame: Baseline and 6 months.
Invasive Tear Film Break-Up Time (ITF-BUT)
Change in tear film stability measured in seconds after fluorescein instillation.
Time frame: Baseline and 6 months.
Schirmer II Test
Change in basal tear film production measured in millimeters (mm) with anesthesia.
Time frame: Baseline and 6 months
5 Ocular Surface Staining (Oxford Scale)
Change in corneal and conjunctival staining evaluated using the Oxford grading schema (Score 0-15).
Time frame: Baseline and 6 months.
6 Meibum Expressibility Score (MES)
Change in meibum expressibility graded from 0 (all glands expressible) to 3 (no glands expressible).
Time frame: Baseline and 6 months.
7 Eyelid Score
Change in eyelid margin signs (telangiectasia, irregularity, obstructed orifices, junction displacement) scored from 0 to 4.
Time frame: Baseline and 6 months.
8 Non-Invasive Tear Film Break-Up Time (NIF-BUT)
Change in tear film stability measured non-invasively using the Sirius device.
Time frame: Baseline and 6 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available beginning 6 months and ending 36 months following the official publication of the study results.
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Jan 2025, 12 months.
Of 199 non-industry interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's 12 months is close to that.
Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Isotretinoin