Autologous Serum Eye DropsNCT07295691
Autologous Serum Eye Drops in Dry Eye Syndrome
A study testing Autologous Serum Eye Drop in people with Autologous Serum Eye Drops and Dry Eye Syndrome, run by The General Authority for Teaching Hospitals and Institutes at 1 site in Egypt.
Trial summary
This study aims to evaluate the clinical efficacy and safety of autologous serum eye drops (ASEDs) in patients with moderate-to-severe dry eye syndrome who are refractory to conventional artificial tear therapy. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Autologous Serum Eye Drops, Dry Eye Syndrome
- What is being tested?
- Autologous Serum Eye Drop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged less than 18 years.
- Both sexes.
- Diagnosed with moderate to severe dry eye syndrome (DES) refractory to artificial tears.
Who cannot join
- Active ocular infection.
- Recent ocular surgery.
- Systemic immunosuppressive therapy.
- History of allergy to blood-derived products.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
The General Authority for Teaching Hospitals and Institutes
Cairo, 11562
Hossam A Hassan, MD, 00201026808348, Dr.hossameabdalfataah@gothi.gov.eg
About this study
Official title: Autologous Serum Eye Drops in Dry Eye Syndrome: Clinical Efficacy and Safety Evaluation
This study aims to evaluate the clinical efficacy and safety of autologous serum eye drops (ASEDs) in patients with moderate-to-severe dry eye syndrome who are refractory to conventional artificial tear therapy.
Read the detailed description
Dry Eye Syndrome (DES) is a highly prevalent ocular condition that significantly affects quality of life, with global prevalence estimated at 5%-50%, depending on population and diagnostic criteria.
Autologous Serum Eye Drops (ASEDs) have emerged as a promising therapy due to their composition, which is rich in vitamin A, epidermal growth factor, fibronectin, and transforming growth factor-β. These components mimic natural tears and promote epithelial healing, reduce inflammation, and enhance tear film stability.
- Conditions
- Autologous Serum Eye Drops, Dry Eye Syndrome
- Being tested
- Autologous Serum Eye Drop
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Serum Eye DropOther
Participants will receive eye drops prepared from their blood serum following a standardized protocol. Specifically, 40 mL of venous blood was collected from each participant at the start of the study and centrifuged at 3000 rpm for 15 min.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Participants will receive eye drops prepared from their blood serum following a standardized protocol. Specifically, 40 mL of venous blood was collected from each participant at the start of the study and centrifuged at 3000 rpm for 15 min. Receives: Other: Autologous Serum Eye Drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Visual acuity will be measured.
Measured: 12 weeks post-procedure
Secondary outcomes (2)
Improvement in Ocular Surface Disease Index (OSDI)
The ocular surface disease index (OSDI) is a comprehensive 12-item questionnaire used to assess the frequency and severity of eye symptoms, the influence of environmental triggers, and the impact of DES on vision-related functionality. The OSDI scores range from 0 to 100, with higher scores indicating greater ocular discomfort and impairment.
Measured: 12 weeks post-procedure
Incidence of adverse events
Incidence of adverse events will be recorded.
Measured: 12 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Sep 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Serum Eye DropsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The General Authority for Teaching Hospitals and Institutes
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Hossam Abdelfattah Husein Hassan, The General Authority for Teaching Hospitals and Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295691
- Sponsor's protocol ID
- HSO00010
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Serum Eye Drops in Dry Eye Syndrome: Clinical Efficacy and Safety Evaluation
- ClinicalTrials.gov ID
- NCT07295691
- Acronym / sponsor ID
- HSO00010
- Conditions
- Autologous Serum Eye Drops, Dry Eye Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The General Authority for Teaching Hospitals and InstitutesResearch network
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Dec 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.
This study aims to evaluate the clinical efficacy and safety of autologous serum eye drops (ASEDs) in patients with moderate-to-severe dry eye syndrome who are refractory to conventional artificial tear therapy.
Detailed description
Dry Eye Syndrome (DES) is a highly prevalent ocular condition that significantly affects quality of life, with global prevalence estimated at 5%-50%, depending on population and diagnostic criteria.
Autologous Serum Eye Drops (ASEDs) have emerged as a promising therapy due to their composition, which is rich in vitamin A, epidermal growth factor, fibronectin, and transforming growth factor-β. These components mimic natural tears and promote epithelial healing, reduce inflammation, and enhance tear film stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Autologous Serum Eye DropParticipants will receive eye drops prepared from their blood serum following a standardized protocol. Specifically, 40 mL of venous blood was collected from each participant at the start of the study and centrifuged at 3000 rpm for 15 min. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children aged less than 18 years.
- Both sexes.
- Diagnosed with moderate to severe dry eye syndrome (DES) refractory to artificial tears.
Key exclusion criteria (4 listed)
- Active ocular infection.
- Recent ocular surgery.
- Systemic immunosuppressive therapy.
- History of allergy to blood-derived products.
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 |
|---|---|---|
| Autologous Serum Eye DropParticipants will receive eye drops prepared from their blood serum following a standardized protocol. Specifically, 40 mL of venous blood was collected from each participant at the start of the study and centrifuged at 3000 rpm for 15 min. | Other | Study group |
Primary outcome
Visual acuity
Time frame: 12 weeks post-procedure
Visual acuity will be measured.
2 secondary outcomes
Improvement in Ocular Surface Disease Index (OSDI)
Time frame: 12 weeks post-procedure
Incidence of adverse events
Time frame: 12 weeks post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Autologous Serum Eye Drops
Recruiting
Study of Proteomic Factors in Patients With Severe Dry Eye Syndrome Treated With Autologous Serum Eye Drops.
Dry Eye Syndrome (DES), Dry Eye
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Serum Eye Drop in people with Autologous Serum Eye Drops and Dry Eye Syndrome, run by The General Authority for Teaching Hospitals and Institutes 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hossam A Hassan, MD (00201026808348, Dr.hossameabdalfataah@gothi.gov.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 12 weeks post-procedure). 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 22 Dec 2025.