Dry EyePhase 3NCT06931041
Comparing Efficacy of Autologous Serum Eye Drops With and Without Insulin in Autoimmune Dry Eye.
A Phase 3 study testing recombinant human insulin and Autologous serum in people with Dry Eye and Sjogren Syndrome, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial summary
Introduction: Dry Eye Disease (DED) of autoimmune origin is often severe and resistant to conventional treatments, necessitating alternative therapeutic options. Autologous Serum Eye Drops (ASED) have gained recognition for their biochemical and biomechanical properties, which closely mimic those of human tears. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Sjogren Syndrome
- What is being tested?
- recombinant human insulin and Autologous serum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2024to 1 Jun 2025
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria included men and women aged 18 years or older with a diagnosis of primary[ and secondary SS confirmed by a rheumatologist using the 2016 ACR-EULAR diagnostic criteria, and moderate to severe DED. Moderate to severe DED was classified using the following standardized parameters: Ocular Surface Disease Index (OSDI) ≥ 23 points, ocular surface staining according to the Van Bijsterveld score ≥ 4 points, non-invasive tear break-up time (NITBUT) ≤ 7 seconds, and tear meniscus height (TMH) ≤ 0.3 mm, measured with the Keratograph 5M (Oculus, Wetzlar, Germany). Participants were required to be willing to comply with the study protocol and follow-up schedule.
Who cannot join
- Exclusion criteria included participation in another clinical trial in the preceding three weeks, topical use of aminoglycoside antibiotics, therapeutic contact lens use, known hypersensitivity to any component of the study medications, active ocular infection, ocular surgery or trauma within three months, or any abnormality compromising corneal integrity. Additionally, patients with a history of corneal transplantation, pregnancy or lactation, or planned pregnancy were excluded.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto de Oftalmologia Conde de Valenciana IAP
Mexico City, Mexico City, 06800
About this study
Official title: Comparing Efficacy of Autologous Serum Eye Drops With and Without Insulin in Autoimmune Dry Eye: A Randomized Clinical Trial
Introduction:
Dry Eye Disease (DED) of autoimmune origin is often severe and resistant to conventional treatments, necessitating alternative therapeutic options. Autologous Serum Eye Drops (ASED) have gained recognition for their biochemical and biomechanical properties, which closely mimic those of human tears. These properties make ASED an effective treatment for DED. Furthermore, topical insulin has demonstrated anti-inflammatory effects and promotes epithelial cell proliferation, differentiation, and migration, all of which contribute to maintaining ocular surface stability. As a result, insulin may serve as a valuable adjunct in treating moderate to severe autoimmune DED.
Read more
Purpose:
This study aims to assess and compare the effectiveness of autologous serum eye drops (group 1) and autologous serum eye drops combined with insulin (group 2) in improving the clinical signs and symptoms of moderate to severe DED in patients with autoimmune diseases, particularly those with Sjögren's Syndrome.
Read the detailed description
Introduction:
Dry Eye Disease (DED) of autoimmune origin is often severe and resistant to conventional treatments, necessitating alternative therapeutic options. Autologous Serum Eye Drops (ASED) have gained recognition for their biochemical and biomechanical properties, which closely mimic those of human tears. These properties make ASED an effective treatment for DED. Furthermore, topical insulin has demonstrated anti-inflammatory effects and promotes epithelial cell proliferation, differentiation, and migration, all of which contribute to maintaining ocular surface stability. As a result, insulin may serve as a valuable adjunct in treating moderate to severe autoimmune DED.
Purpose:
This study aims to assess and compare the effectiveness of autologous serum eye drops (group 1) and autologous serum eye drops combined with insulin (group 2) in improving the clinical signs and symptoms of moderate to severe DED in patients with autoimmune diseases, particularly those with Sjögren's Syndrome.
- Conditions
- Dry Eye, Sjogren Syndrome
- Being tested
- recombinant human insulin, Autologous serum
- Keywords
- Dry eye, Sjogren Syndrome, Insulin, Autologous Serum
- Medical subject headings
- Dry Eye Syndromes, Sjogren's Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human insulinDrug
1 UI/ml of insulin added to the autologous serum formulation.
Autologous serumOther
Autologous Serum
| Study group | Role | What they receive |
|---|---|---|
| Insulin | Active comparator | 1 UI/ml of insulin added to the autologous serum formulation. Receives: Drug: recombinant human insulin; Other: Autologous serum |
| Sham | Sham comparator | Autologous Serum without insulin. Receives: Other: Autologous serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI
Ocular Surface Disease Index
Measured: From enrollment, 10 days and 30 days after starting treatment.
Secondary outcomes (4)
Ocular surface staining (Van-Bijsterveld score)
Measured: From enrollment, 10 days and 30 days after starting treatment.
Schirmer test
Measured: From enrollment, 10 days and 30 days after starting treatment.
non-invasive tear break-up time (NITBUT)
Measured: From enrollment, 10 days and 30 days after starting treatment.
Tear meniscus height (TMH)
Measured: From enrollment, 10 days and 30 days after starting treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 Feb 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, single-blinded clinical trial will include patients aged 18 years and older who are diagnosed with moderate to severe DED associated with primary (PSS) or secondary (SSS) Sjögren's Syndrome. Both groups will receive ASED at a concentration of 30%. In group 2, 1 UI/ml of insulin will be added to the ASED formulation. The dosage will consist of one drop every 6 hours for 30 days in both groups. The following parameters will be evaluated at baseline (day 0), day 10, and day 30 of treatment: best corrected visual acuity (BCVA), ocular surface staining (Van-Bijsterveld score), Schirmer test, non-invasive tear break-up time (NITBUT), tear meniscus height (TMH), bulbar conjunctival hyperemia (BCH), and Ocular Surface Disease Index (OSDI) score. Statistical analysis will be performed using ANOVA for time/group comparisons with STATA 18.0 software.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931041
- Sponsor's protocol ID
- CEI-2023/10/04
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy of Autologous Serum Eye Drops With and Without Insulin in Autoimmune Dry Eye: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06931041
- Acronym / sponsor ID
- CEI-2023/10/04
- Conditions
- Dry Eye, Sjogren Syndrome
- Keywords
- Dry eye, Sjogren Syndrome, Insulin, Autologous Serum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 16 Apr 2025 (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.
Introduction:
Dry Eye Disease (DED) of autoimmune origin is often severe and resistant to conventional treatments, necessitating alternative therapeutic options. Autologous Serum Eye Drops (ASED) have gained recognition for their biochemical and biomechanical properties, which closely mimic those of human tears. These properties make ASED an effective treatment for DED. Furthermore, topical insulin has demonstrated anti-inflammatory effects and promotes epithelial cell proliferation, differentiation, and migration, all of which contribute to maintaining ocular surface stability. As a result, insulin may serve as a valuable adjunct in treating moderate to severe autoimmune DED.
Purpose:
This study aims to assess and compare the effectiveness of autologous serum eye drops (group 1) and autologous serum eye drops combined with insulin (group 2) in improving the clinical signs and symptoms of moderate to severe DED in patients with autoimmune diseases, particularly those with Sjögren's Syndrome.
Detailed description
Introduction:
Dry Eye Disease (DED) of autoimmune origin is often severe and resistant to conventional treatments, necessitating alternative therapeutic options. Autologous Serum Eye Drops (ASED) have gained recognition for their biochemical and biomechanical properties, which closely mimic those of human tears. These properties make ASED an effective treatment for DED. Furthermore, topical insulin has demonstrated anti-inflammatory effects and promotes epithelial cell proliferation, differentiation, and migration, all of which contribute to maintaining ocular surface stability. As a result, insulin may serve as a valuable adjunct in treating moderate to severe autoimmune DED.
Purpose:
This study aims to assess and compare the effectiveness of autologous serum eye drops (group 1) and autologous serum eye drops combined with insulin (group 2) in improving the clinical signs and symptoms of moderate to severe DED in patients with autoimmune diseases, particularly those with Sjögren's Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized, single-blinded clinical trial will include patients aged 18 years and older who are diagnosed with moderate to severe DED associated with primary (PSS) or secondary (SSS) Sjögren's Syndrome. Both groups will receive ASED at a concentration of 30%. In group 2, 1 UI/ml of insulin will be added to the ASED formulation. The dosage will consist of one drop every 6 hours for 30 days in both groups. The following parameters will be evaluated at baseline (day 0), day 10, and day 30 of treatment: best corrected visual acuity (BCVA), ocular surface staining (Van-Bijsterveld score), Schirmer test, non-invasive tear break-up time (NITBUT), tear meniscus height (TMH), bulbar conjunctival hyperemia (BCH), and Ocular Surface Disease Index (OSDI) score. Statistical analysis will be performed using ANOVA for time/group comparisons with STATA 18.0 software.
| Arm | Type | Receives |
|---|---|---|
| Insulin | Active comparator | Drug: recombinant human insulin, Other: Autologous serum1 UI/ml of insulin added to the autologous serum formulation. |
| Sham | Sham comparator | Other: Autologous serumAutologous Serum without insulin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria included men and women aged 18 years or older with a diagnosis of primary[ and secondary SS confirmed by a rheumatologist using the 2016 ACR-EULAR diagnostic criteria, and moderate to severe DED. Moderate to severe DED was classified using the following standardized parameters: Ocular Surface Disease Index (OSDI) ≥ 23 points, ocular surface staining according to the Van Bijsterveld score ≥ 4 points, non-invasive tear break-up time (NITBUT) ≤ 7 seconds, and tear meniscus height (TMH) ≤ 0.3 mm, measured with the Keratograph 5M (Oculus, Wetzlar, Germany). Participants were required to be willing to comply with the study protocol and follow-up schedule.
Key exclusion criteria (1 listed)
- Exclusion criteria included participation in another clinical trial in the preceding three weeks, topical use of aminoglycoside antibiotics, therapeutic contact lens use, known hypersensitivity to any component of the study medications, active ocular infection, ocular surgery or trauma within three months, or any abnormality compromising corneal integrity. Additionally, patients with a history of corneal transplantation, pregnancy or lactation, or planned pregnancy were excluded.
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 |
|---|---|---|
| recombinant human insulin1 UI/ml of insulin added to the autologous serum formulation. | Drug | Insulin |
| Autologous serumAutologous Serum | Other | Insulin, Sham |
Primary outcome
OSDI
Time frame: From enrollment, 10 days and 30 days after starting treatment.
Ocular Surface Disease Index
4 secondary outcomes
Ocular surface staining (Van-Bijsterveld score)
Time frame: From enrollment, 10 days and 30 days after starting treatment.
Schirmer test
Time frame: From enrollment, 10 days and 30 days after starting treatment.
non-invasive tear break-up time (NITBUT)
Time frame: From enrollment, 10 days and 30 days after starting treatment.
Tear meniscus height (TMH)
Time frame: From enrollment, 10 days and 30 days after starting treatment.
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 27 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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 Phase 3 study testing recombinant human insulin and Autologous serum in people with Dry Eye and Sjogren Syndrome, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
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 1 inclusion and 1 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 27 Aug 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 Mexico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
OSDI (time frame: From enrollment, 10 days and 30 days after starting treatment.). 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 27 Aug 2026.