Dry EyePhase 3NCT03436576
Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye
A Phase 3 study testing Autologous Serum 20% and Autologous Serum 50% in people with Dry Eye and Keratoconjunctivitis Sicca, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The purpose of this study is to compare the effects of autologous serum 20% and autologous serum 50% for the treatment of Severe Dry Eye Syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Keratoconjunctivitis Sicca, Sjogren's Syndrome
- What is being tested?
- Autologous Serum 20% and Autologous Serum 50%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChile
- Study dates
- 12 Sep 2018to 19 Nov 2018
- 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
- Man/woman ≥ 18 years old, able to freely give consent to participate in the study
- At least 1 of the following tests altered:
- Ocular Surface Disease Index (OSDI) Test symptoms > 32
- BUT ≤5 seconds
- Oxford staining ≥ 3
- Schirmer Test without anesthesia ≤ 5 mm
Who cannot join
- Sensitivity or known intolerance to any of the products used in the study
- Contraindication of venipuncture
- Story of ocular infections within the 6 previous months to study inclusion
- Any active ocular pathology other than Dry Eye Syndrome
- Use of contact lenses in the 3 previous months to study inclusion
- No pregnant or breastfeeding women is allowed to participate in the study. Childbearing potential women must use contraceptive means during the whole study.
- Participation in another clinical trial in the last 30 days before study inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Autologous Serum 20% and Autologous Serum 50% for the Treatment of Severe Dry Eye
The purpose of this study is to compare the effects of autologous serum 20% and autologous serum 50% for the treatment of Severe Dry Eye Syndrome
Read the detailed description
To determine the difference between autologous serum 20% vs 50%, in terms of improvement of symptoms, improvement of ocular surface parameters and acceptable tolerability in patients with severe dry eye syndrome.
- Conditions
- Dry Eye, Keratoconjunctivitis Sicca, Sjogren's Syndrome, Corneal Diseases, Conjunctival Diseases, Keratitis
- Being tested
- Autologous Serum 20%, Autologous Serum 50%
- Keywords
- Autologous serum, Concentration, Autologous serum 20%, Autologous serum 50%, Severe dry eye
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca, Sjogren's Syndrome, Corneal Diseases, Conjunctival Diseases, Keratitis, Lacrimal Apparatus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Serum 20%Drug
Also called Autologus serum low concentration
Instillation of 1 drop of Autologous Serum 20% four times a day
Autologous Serum 50%Drug
Also called Autologus serum high concentration
Instillation of 1 drop of Autologous Serum 50% four times a day
| Study group | Role | What they receive |
|---|---|---|
| Autologous Serum 20% | Active comparator | Treatment with Autologous Serum 20% for 2 months Receives: Drug: Autologous Serum 20% |
| Autologous Serum 50% | Active comparator | Treatment with Autologous Serum 50% for 2 months Receives: Drug: Autologous Serum 50% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ocular Surface Disease Index (OSDI) Score
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning.
The overall OSDI score defines the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.
Measured: 1 month
Secondary outcomes (4)
Change in Tear Break Up Time (TBUT)
The TBUT is based on the time of tear rupture after the instillation of fluorescein.
The shorter the time of rupture, the greater the tear dysfunction
Measured: 1 week, 1 month, 2 months
Change in Oxford Staining score
The Oxford scale is based on the amount of ocular surface (cornea and conjunctiva) that is stained with lysine or green fluorescein. The severity of the staining points is classified into 6 stages (0-5) from absent to marked epithelial damage.
Measured: 1 week, 1 month, 2 months
Change in Schirmer I
It is a tear production test. The Schirmer I test is performed without anesthesia. Two thin strips of filter paper (Whatman 5mm x 35mm) are placed on the bottom of the lower conjunctival sac at the junction of the middle third and the outer third to prevent injury to the cornea. It is recommended to ask the subject to keep their eyes closed to limit the effect of blinking. The strips are kept positioned for 5 minutes and then they are removed and the amount that was moistened is read, in mm.
The lower the value, the greater the deficit of tear production
Measured: 1 week, 1 month, 2 months
Change in Ocular Surface Disease Index (OSDI) Score
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning.
The overall OSDI score defines the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.
Measured: 1 week, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start12 Sep 2018 (estimated)
- Primary completion19 Oct 2018 (estimated)
- Study completion19 Nov 2018 (estimated)
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.
- More trials run by Pontificia Universidad Catolica de ChileThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Dr Sotero del Rio
- Responsible party
- Sponsor
- Investigators
- Paulina Liberman, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436576
- Sponsor's protocol ID
- SERUM2050
- Status last verified
- Aug 2018
- First submitted
- 12 Feb 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Autologous Serum 20% and Autologous Serum 50% for the Treatment of Severe Dry Eye
- ClinicalTrials.gov ID
- NCT03436576
- Acronym / sponsor ID
- SERUM2050
- Conditions
- Dry Eye, Keratoconjunctivitis Sicca, Sjogren's Syndrome, Corneal Diseases, Conjunctival Diseases, Keratitis
- Keywords
- Autologous serum, Concentration, Autologous serum 20%, Autologous serum 50%, Severe dry eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Hospital Dr Sotero del Rio
- Study start
- 12 Sep 2018 (estimated)
- Primary completion
- 19 Oct 2018 (estimated)
- Study completion
- 19 Nov 2018 (estimated)
- First posted
- 19 Feb 2018 (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 purpose of this study is to compare the effects of autologous serum 20% and autologous serum 50% for the treatment of Severe Dry Eye Syndrome
Detailed description
To determine the difference between autologous serum 20% vs 50%, in terms of improvement of symptoms, improvement of ocular surface parameters and acceptable tolerability in patients with severe dry eye syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Serum 20% | Active comparator | Drug: Autologous Serum 20%Treatment with Autologous Serum 20% for 2 months |
| Autologous Serum 50% | Active comparator | Drug: Autologous Serum 50%Treatment with Autologous Serum 50% for 2 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Man/woman ≥ 18 years old, able to freely give consent to participate in the study
- At least 1 of the following tests altered:
Key exclusion criteria (7 listed)
- Sensitivity or known intolerance to any of the products used in the study
- Contraindication of venipuncture
- Story of ocular infections within the 6 previous months to study inclusion
- Any active ocular pathology other than Dry Eye Syndrome
- Use of contact lenses in the 3 previous months to study inclusion
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 20%Also: Autologus serum low concentrationInstillation of 1 drop of Autologous Serum 20% four times a day | Drug | Autologous Serum 20% |
| Autologous Serum 50%Also: Autologus serum high concentrationInstillation of 1 drop of Autologous Serum 50% four times a day | Drug | Autologous Serum 50% |
Primary outcome
Change in Ocular Surface Disease Index (OSDI) Score
Time frame: 1 month
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The overall OSDI score defines the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.
4 secondary outcomes
Change in Tear Break Up Time (TBUT)
Time frame: 1 week, 1 month, 2 months
Change in Oxford Staining score
Time frame: 1 week, 1 month, 2 months
Change in Schirmer I
Time frame: 1 week, 1 month, 2 months
Change in Ocular Surface Disease Index (OSDI) Score
Time frame: 1 week, 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Paulina Liberman, MD principal investigator
Pontificia Universidad Catolica de Chile
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 Autologous Serum 20% and Autologous Serum 50% in people with Dry Eye and Keratoconjunctivitis Sicca, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 6 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: status not confirmed, as of the sponsor's last update on 5 Sep 2018. 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 Chile. 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.
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?
Results are not available in the source record.
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?
Change in Ocular Surface Disease Index (OSDI) Score (time frame: 1 month). 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 5 Sep 2018.