Dry Eye SyndromesNCT04015219
Management of Signs and Symptoms Associated With Dry Eye Disease
A study testing Self retained cryopreserved amniotic membrane and lifitegrast ophthalmic solution in people with Dry Eye Syndromes, run by BioTissue Holdings, Inc at 1 site in United States.
Trial summary
A prospective randomized, and controlled study to compare the effectiveness of PROKERA® SLIM plus standard of care (SOC) in the PROKERA® SLIM Arm to SOC alone in the Control Arm. Subjects presenting with moderate DED defined as corneal fluorescein staining score of ≥ 3 points out of 9 will be recruited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Self retained cryopreserved amniotic membrane and lifitegrast ophthalmic solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2018to 5 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects with moderate dry eye defined as corneal fluorescein staining score of ≥ 3
- Age ≥ 18 years
- Distance best corrected visual acuity better than 20/60 Snellen equivalent in each eye
- Willing to sign a written informed consent to participate
- Able to follow study instructions, with the intention of completing all required visits
Who cannot join
- Presence of persistent corneal epithelial defect or ulcer in either eye
- Presence of active ocular infection in either eye
- Presence of ocular inflammation that is not related to keratoconjunctivitis sicca, e.g., allergy, severe blepharitis
- Presence of other corneal disorder(s) that give rise to reduced corneal sensitivity, such as recurrent herpes keratitis
- Presence of corneal diseases other than dry eye that can disturb the pre-corneal tear film such as epithelial basement membrane dystrophy (EBMD)
- Contact lens wear
Show all 12Show fewer
- History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK
- Presence of cicatricial ocular surface diseases
- A medical or ocular condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial
- Any scheduled or planned ocular or systemic surgery or procedure during the study
- Pregnancy and women who are expecting to be pregnant.
- Current enrolment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Center of Excellence in Eye Care
Miami, Florida, 33176
About this study
Official title: A Prospective, Randomized, and Controlled Clinical Study to Evaluate PROKERA® in the Management of Signs and Symptoms Associated With Dry Eye Disease
A prospective randomized, and controlled study to compare the effectiveness of PROKERA® SLIM plus standard of care (SOC) in the PROKERA® SLIM Arm to SOC alone in the Control Arm. Subjects presenting with moderate DED defined as corneal fluorescein staining score of ≥ 3 points out of 9 will be recruited.
- Conditions
- Dry Eye Syndromes
- Being tested
- Self retained cryopreserved amniotic membrane, lifitegrast ophthalmic solution
- 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.
Self retained cryopreserved amniotic membraneDevice
PROKERA SLIM
lifitegrast ophthalmic solutionOther
Also called Xiidra
Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | PROKERA SLIM + Standard of Care Receives: Device: Self retained cryopreserved amniotic membrane; Other: lifitegrast ophthalmic solution |
| Control Arm | Active comparator | Standard of Care Receives: Other: lifitegrast ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Fluorescein Staining
corneal fluorescein staining score of study eye graded from 0 to 9, with a score of 9 being worse. The corneal fluorescein staining score is the sum of three scores by subdividing the entire cornea into upper 1/3, middle 1/3, and lower 1/3, of which each is graded from 0 (no staining) to 3 (diffuse staining).
Measured: 1 month
Secondary outcomes (2)
Eye Dryness Score
Patient subjectively evaluates eye dryness score using a visual analog scale from 0 to 100 maximal discomfort
Measured: 1 month
Ocular Surface Disease Index (OSDI)
Patient subjectively evaluates OSDI questionnaire, OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability
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 posted10 Jul 2019
- Study start18 Jul 2018
- Primary completion5 Oct 2020
- Study completion5 Oct 2020
Why it stopped: enrollment constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioTissue Holdings, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015219
- Sponsor's protocol ID
- PROKERA-CS001
- Status last verified
- Dec 2022
- First submitted
- 8 Jul 2019
- Last updated
- 23 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, and Controlled Clinical Study to Evaluate PROKERA® in the Management of Signs and Symptoms Associated With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04015219
- Acronym / sponsor ID
- PROKERA-CS001
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment constraints
- Enrolment
- 3 participants (actual)
- Lead sponsor
- BioTissue Holdings, IncIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Posted 23 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective randomized, and controlled study to compare the effectiveness of PROKERA® SLIM plus standard of care (SOC) in the PROKERA® SLIM Arm to SOC alone in the Control Arm. Subjects presenting with moderate DED defined as corneal fluorescein staining score of ≥ 3 points out of 9 will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Self retained cryopreserved amniotic membrane, Other: lifitegrast ophthalmic solutionPROKERA SLIM + Standard of Care |
| Control Arm | Active comparator | Other: lifitegrast ophthalmic solutionStandard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with moderate dry eye defined as corneal fluorescein staining score of ≥ 3
- Age ≥ 18 years
- Distance best corrected visual acuity better than 20/60 Snellen equivalent in each eye
- Willing to sign a written informed consent to participate
- Able to follow study instructions, with the intention of completing all required visits
Key exclusion criteria (12 listed)
- Presence of persistent corneal epithelial defect or ulcer in either eye
- Presence of active ocular infection in either eye
- Presence of ocular inflammation that is not related to keratoconjunctivitis sicca, e.g., allergy, severe blepharitis
- Presence of other corneal disorder(s) that give rise to reduced corneal sensitivity, such as recurrent herpes keratitis
- Presence of corneal diseases other than dry eye that can disturb the pre-corneal tear film such as epithelial basement membrane dystrophy (EBMD)
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 |
|---|---|---|
| Self retained cryopreserved amniotic membranePROKERA SLIM | Device | Treatment Arm |
| lifitegrast ophthalmic solutionAlso: XiidraXiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA) | Other | Control Arm, Treatment Arm |
Primary outcome
Corneal Fluorescein Staining
Time frame: 1 month
corneal fluorescein staining score of study eye graded from 0 to 9, with a score of 9 being worse. The corneal fluorescein staining score is the sum of three scores by subdividing the entire cornea into upper 1/3, middle 1/3, and lower 1/3, of which each is graded from 0 (no staining) to 3 (diffuse staining).
2 secondary outcomes
Eye Dryness Score
Time frame: 1 month
Ocular Surface Disease Index (OSDI)
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 study testing Self retained cryopreserved amniotic membrane and lifitegrast ophthalmic solution in people with Dry Eye Syndromes, run by BioTissue Holdings, Inc at 1 site in United States.
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 12 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: stopped early, as of the sponsor's last update on 23 Dec 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Corneal Fluorescein 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 23 Dec 2022.