Dry Eye SyndromesPhase 3NCT05598242
Amniotic Membrane Treatment for Hyposecretory Dry Eye
A Phase 3 study testing Amniotic membrane extract eye drops (AMEED) in people with Dry Eye Syndromes and Sjogren Syndrome With Keratoconjunctivitis, run by Hospital Nacional Profesor Alejandro Posadas at 3 sites in Argentina.
Trial summary
The goal of this randomized, active-controlled, parallel-group trial is to evaluate the clinical efficacy of amniotic membrane extract eye drops (AMEED) in reducing signs and symptoms of hyposecretory dry eye Participants will receibed amniotic membrane extract eye drops 6 times daily and was evaluated at baseline day… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Dry Eye Syndromes, Sjogren Syndrome With Keratoconjunctivitis
- What is being tested?
- Amniotic membrane extract eye drops (AMEED)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesArgentina
- Study dates
- 1 Feb 2019to 15 Dec 2019
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years of age or older
- dry eye related symptoms
- Fluorescein Corneal Staining score of 4 or more
- Lisamina Green Conjunctival score of 4 or more
- a no-anesthesia Schirmer test value at 5' of 10 mm or less
Who cannot join
- glaucoma treatment
- surgical procedures within 3 months of the baseline evaluation
- precense of punctal plug
- patients that were human immunodeficiency virus positive
Trial locations and contacts
3 sites in 1 country.
Argentina3 sites
Hospital Nacional Posadas
El Palomar, Buenos Aires, 1649
Hospital Nacional Prof. A. Posadas
El Palomar, Buenos Aires, 1649
Hospital Nacional Profesor A. Posadas
El Palomar, Buenos Aires, 1684
About this study
The goal of this randomized, active-controlled, parallel-group trial is to evaluate the clinical efficacy of amniotic membrane extract eye drops (AMEED) in reducing signs and symptoms of hyposecretory dry eye
Participants will receibed amniotic membrane extract eye drops 6 times daily and was evaluated at baseline day and day 30th.
Researchers will compare against autologous serum eye drops effects
Read the detailed description
This was a randomized, active-controlled, parallel-group trial. The perfect masked conditions could not be accomplished because the autologous serum eye drops needs venous punction for it preparation.
During de initial 2 weeks screening period, the patients received artificial tears 4 times daily to minimize the effects of any eye drops used before patients were allocated randomly to receive autologous serum eye drops (ASED) or AMEED, administered as 1 drop in each eye 6 times daily, respectively, for 30 days.
- Being tested
- Amniotic membrane extract eye drops (AMEED)
- Keywords
- dry eye, autologous serum, amniotic membrane extract eye drops
- 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.
Amniotic membrane extract eye drops (AMEED)Biological
Also called Autologous serum
Following a 2-week wash out period, patients were allocated randomly to receive AMEED, administered as 1 drop in each eye 6 times daily, respectively, for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Amniotic membrane extract | Experimental | patients receive amniotic membrane eye drops (AMEED) as 1 drop in each eye 6 times daily, 30 days Receives: Biological: Amniotic membrane extract eye drops (AMEED) |
| autologous serum eye drops | Active comparator | patients receive autologous serum eye drops (ASED) as 1 drop in each eye 6 times daily, 30 days Receives: Biological: Amniotic membrane extract eye drops (AMEED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lisamina green conjunctival staining
changes in the lisamina green conjunctival staining (LGCS) score to demonstrate ocular surface damage
Measured: 1 month
Secondary outcomes (4)
Fluorescein Corneal staining
fluorescein corneal staining (FCS) score to demostrate corneal ephithelium involment
Measured: 1 month
Schirmer's test
Schirmer´s test to asses lacrimal production whithout anesthesia
Measured: 1 month
TBUT
tear film break up time
Measured: 1 month
OSDI
severity of symptoms reported by patients according to the ocular surface disease index (OSDI)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Feb 2019
- Primary completion1 Sep 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- active-controlled, parallel-group trial
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nacional Profesor Alejandro Posadas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emiliano Facundo Ross, Hospital Nacional Profesor Alejandro Posadas
- Investigators
- Emiliano F Ross, MD, Principal investigator, assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598242
- Sponsor's protocol ID
- 192 LUPeSe/18 (ENM)
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amniotic Membrane Treatment for Hyposecretory Dry Eye
- ClinicalTrials.gov ID
- NCT05598242
- Acronym / sponsor ID
- 192 LUPeSe/18 (ENM)
- Keywords
- dry eye, autologous serum, amniotic membrane extract eye drops
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospital Nacional Profesor Alejandro PosadasUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 28 Oct 2022 (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 goal of this randomized, active-controlled, parallel-group trial is to evaluate the clinical efficacy of amniotic membrane extract eye drops (AMEED) in reducing signs and symptoms of hyposecretory dry eye
Participants will receibed amniotic membrane extract eye drops 6 times daily and was evaluated at baseline day and day 30th.
Researchers will compare against autologous serum eye drops effects
Detailed description
This was a randomized, active-controlled, parallel-group trial. The perfect masked conditions could not be accomplished because the autologous serum eye drops needs venous punction for it preparation.
During de initial 2 weeks screening period, the patients received artificial tears 4 times daily to minimize the effects of any eye drops used before patients were allocated randomly to receive autologous serum eye drops (ASED) or AMEED, administered as 1 drop in each eye 6 times daily, respectively, for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- active-controlled, parallel-group trial
| Arm | Type | Receives |
|---|---|---|
| Amniotic membrane extract | Experimental | Biological: Amniotic membrane extract eye drops (AMEED)patients receive amniotic membrane eye drops (AMEED) as 1 drop in each eye 6 times daily, 30 days |
| autologous serum eye drops | Active comparator | Biological: Amniotic membrane extract eye drops (AMEED)patients receive autologous serum eye drops (ASED) as 1 drop in each eye 6 times daily, 30 days |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21 years of age or older
- dry eye related symptoms
- Fluorescein Corneal Staining score of 4 or more
- Lisamina Green Conjunctival score of 4 or more
- a no-anesthesia Schirmer test value at 5' of 10 mm or less
Key exclusion criteria (4 listed)
- glaucoma treatment
- surgical procedures within 3 months of the baseline evaluation
- precense of punctal plug
- patients that were human immunodeficiency virus positive
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 |
|---|---|---|
| Amniotic membrane extract eye drops (AMEED)Also: Autologous serumFollowing a 2-week wash out period, patients were allocated randomly to receive AMEED, administered as 1 drop in each eye 6 times daily, respectively, for 30 days. | Biological | Amniotic membrane extract, autologous serum eye drops |
Primary outcome
Lisamina green conjunctival staining
Time frame: 1 month
changes in the lisamina green conjunctival staining (LGCS) score to demonstrate ocular surface damage
4 secondary outcomes
Fluorescein Corneal staining
Time frame: 1 month
Schirmer's test
Time frame: 1 month
TBUT
Time frame: 1 month
OSDI
Time frame: 1 month
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 28 Oct 2022.
- 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.
Emiliano F Ross, MD principal investigator
assistant
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amniotic membrane extract eye drops (AMEED) in people with Dry Eye Syndromes and Sjogren Syndrome With Keratoconjunctivitis, run by Hospital Nacional Profesor Alejandro Posadas at 3 sites in Argentina.
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 5 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: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Argentina. 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?
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?
Lisamina green conjunctival staining (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 28 Oct 2022.