Dry Eye Disease (DED)NCT07753811
Effect of Oral Isotretinoin on Ocular Surface and Meibomian Glands
A study testing isotretinoin in people with Dry Eye Disease (DED) and Meibomian Gland Dysfunction (Disorder), run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease (DED), Meibomian Gland Dysfunction (Disorder), Acne Vulgaris
- What is being tested?
- isotretinoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effect of Oral Isotretinoin for Acne Treatment on the Ocular Surface and the Morphology of the Meibomian Gland
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.
Read the detailed description
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.
- Being tested
- isotretinoin
- Keywords
- dry eye, isotretinoin, acne, Meibomian gland
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isotretinoinDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| Isotretinoin Group | Active comparator | Low-dose oral isotretinoin therapy for patients with clinically diagnosed acne vulgaris. Receives: Drug: isotretinoin |
| Control Group | No intervention | Age- and gender-matched healthy participants without acne vulgaris. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 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.
Measured: Baseline and 6 months.
Secondary outcomes (6)
Invasive Tear Film Break-Up Time (ITF-BUT)
Change in tear film stability measured in seconds after fluorescein instillation.
Measured: Baseline and 6 months.
Schirmer II Test
Change in basal tear film production measured in millimeters (mm) with anesthesia.
Measured: 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).
Measured: Baseline and 6 months.
6 Meibum Expressibility Score (MES)
Change in meibum expressibility graded from 0 (all glands expressible) to 3 (no glands expressible).
Measured: Baseline and 6 months.
7 Eyelid Score
Change in eyelid margin signs (telangiectasia, irregularity, obstructed orifices, junction displacement) scored from 0 to 4.
Measured: 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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Jan 2024
- Primary completion1 Jan 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohamed Shams, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753811
- Sponsor's protocol ID
- isotretinoin and dry eye
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Oral Isotretinoin for Acne Treatment on the Ocular Surface and the Morphology of the Meibomian Gland
- ClinicalTrials.gov ID
- NCT07753811
- Acronym / sponsor ID
- isotretinoin and dry eye
- Keywords
- dry eye, isotretinoin, acne, Meibomian gland
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotretinoin Group | Active comparator | Drug: isotretinoinLow-dose oral isotretinoin therapy for patients with clinically diagnosed acne vulgaris. |
| Control Group | No intervention | –Age- and gender-matched healthy participants without acne vulgaris. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isotretinoin1. 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 | Drug | Isotretinoin Group |
Primary outcome
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 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.
6 secondary outcomes
Invasive Tear Film Break-Up Time (ITF-BUT)
Time frame: Baseline and 6 months.
Schirmer II Test
Time frame: Baseline and 6 months
5 Ocular Surface Staining (Oxford Scale)
Time frame: Baseline and 6 months.
6 Meibum Expressibility Score (MES)
Time frame: Baseline and 6 months.
7 Eyelid Score
Time frame: Baseline and 6 months.
8 Non-Invasive Tear Film Break-Up Time (NIF-BUT)
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isotretinoin in people with Dry Eye Disease (DED) and Meibomian Gland Dysfunction (Disorder), run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 Meibomian Gland Morphology (Meiboscore) (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.