Dry Eye SyndromesNCT05121493
Study of Platelet Rich Plasma Drops to Moderate Clinically Significant Dry Eye
A study testing Platelet Poor Plasma Tear Drops and Platelet Rich Plasma Tear Drops in people with Dry Eye Syndromes, run by University of Rochester at 1 site in United States.
Trial summary
This is a single center double-masked study with up to four visits. Subjects who have been diagnosed with dry-eye syndrome at Flaum Eye Institute will be enrolled. The purpose of the study is to determine if using platelet rich plasma drops can improve clinically significant dry eye in patients and determine if there… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Platelet Poor Plasma Tear Drops and Platelet Rich Plasma Tear Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 1 Jun 2028
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be diagnosed with clinically significant dry eye.
- Subjects have no active ocular disease or allergic conjunctivitis.
- Subjects must not be using any topical ocular medications within two weeks prior to enrollment.
- Subjects must be willing and able to follow instructions.
- Subjects must have voluntarily agreed to participate in the study by signing the statement of informed consent.
- Subjects must meet plasma donor criteria as established by University of Rochester Transfusion Medicine \& Blood Bank.
Who cannot join
- Is pregnant at the time of enrolment in the study determined by urine pregnancy test.
- Is currently on a course of antibiotics
- Is considered by the Investigator to not be a suitable candidate for participation and are not at risk for glaucoma.
- Is considered by the University of Rochester Transfusion Medicine \& Blood Bank not a suitable candidate for blood donation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Flaum Eye Institute at the University of Rochester
Rochester, New York, 14642
About this study
This is a single center double-masked study with up to four visits. Subjects who have been diagnosed with dry-eye syndrome at Flaum Eye Institute will be enrolled. The purpose of the study is to determine if using platelet rich plasma drops can improve clinically significant dry eye in patients and determine if there is a difference with using two different uses of the plasma tear drops: platelet rich plasma tears and plasma tears without platelets.
- Conditions
- Dry Eye Syndromes
- Being tested
- Platelet Poor Plasma Tear Drops, Platelet Rich Plasma Tear 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.
Platelet Poor Plasma Tear DropsOther
Participant blood will be drawn and processed by the University of Rochester Transfusion Medicine and Blood Bank. Processing will isolate the platelet free fraction of the blood plasma. After processing, plasma should contain ≤ 5% concentration of white blood cells (WBC), red blood cells (RBC), and platelets when compared to the concentration before processing.
Platelet Rich Plasma Tear DropsOther
Participant blood will be drawn and processed by the University of Rochester Transfusion Medicine and Blood Bank. Processing will isolate the platelet fraction of the blood plasma. After processing, plasma should contain ≤ 5% concentration of WBC and RBC and 100 x 10³ μl or ≥ 50% recovery of platelets when compared to the pre-platelet count.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Poor Plasma Tear | Active comparator | Not described Receives: Other: Platelet Poor Plasma Tear Drops |
| Platelet Rich Plasma Tears | Experimental | Not described Receives: Other: Platelet Rich Plasma Tear Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in acuity
Acuity will be measured using a Shack-Hartmann Wavefront Sensor. Subjects will be seated in front of the wavefront sensor. They will be asked to blink naturally fixate on the laser spot throughout the measurement protocol. While subjects fixate, the wavefront sensor delivers a brief flash of light to the subjects' retina. The light reflected out of the subjects' eye is collected to obtain measurements of wavefront aberrations of the eye. For optical quality assessments the measurements of wavefront aberrations will be acquired along the line-of-sight. The wavefront data acquired from the wavefront sensor will be described by Zernike coefficients, the most popular mathematical way to represent the ocular aberrations.
Measured: baseline to 3 months
Mean change in breakup pattern to appear
This will be measured using a Placido Disk. The subject places their chin on a chin rest and look into the disk system. The system uses an incandescent or broad-band area LED for illumination.
Measured: baseline to 3 months
Mean change in lipid coverage of the cornea with blinking
This will be measured using a Ellipsometer/Tearscope. This instrument uses a modified slit-lamp head restraint and an imaging system to visualize the surface of the subject's cornea. Structurally the system is a clinical slit-lamp system. However, the system uses an electronic camera instead of a human observer. The illumination system uses a diffuse ring illuminator instead of a slit-lamp. The data from this instrument identifies changes in the lipid thickness and the refractive index over the cornea.
Measured: baseline to 3 months
Mean change in consistency of lipid compensation
This will be measured using a Ellipsometer/Tearscope. This instrument uses a modified slit-lamp head restraint and an imaging system to visualize the surface of the subject's cornea. Structurally the system is a clinical slit-lamp system. However, the system uses an electronic camera instead of a human observer. The illumination system uses a diffuse ring illuminator instead of a slit-lamp. The data from this instrument identifies changes in the lipid thickness and the refractive index over the cornea.
Measured: baseline to 3 months
Mean change in temperature over the optical service
This will be measured using a Thermal Imaging System. A thermal imaging system will be used to provide spatially-resolved thermal maps of the subject's eyes and face adjacent to the eyes. This camera system is non-invasive and is mounted on a tripod about 12" from the subject's eyes. It images the heat that is emitted by the subject at frame rates from 2 to 10 Hz. The camera displays a spatially resolved map (approximately 0.2 x 0.2 mm pixel size) of the ocular surface temperature. IR detection is a convenient tool for instantaneous temperature measurement of the ocular surface and allows monitoring of time course change as well.
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Jan 2027 (estimated)
- Primary completion15 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Why it stopped: The Principal Investigator passed away prior to study initiation. The study was withdrawn before enrollment began.
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.
- More trials run by University of RochesterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121493
- Sponsor's protocol ID
- STUDY00004552
- Status last verified
- Jan 2026
- First submitted
- 3 Nov 2021
- Last updated
- 16 Jul 2026
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Platelet Rich Plasma Drops to Moderate Clinically Significant Dry Eye
- ClinicalTrials.gov ID
- NCT05121493
- Acronym / sponsor ID
- STUDY00004552
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Principal Investigator passed away prior to study initiation. The study was withdrawn before enrollment began.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 16 Nov 2021 (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 is a single center double-masked study with up to four visits. Subjects who have been diagnosed with dry-eye syndrome at Flaum Eye Institute will be enrolled. The purpose of the study is to determine if using platelet rich plasma drops can improve clinically significant dry eye in patients and determine if there is a difference with using two different uses of the plasma tear drops: platelet rich plasma tears and plasma tears without platelets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Poor Plasma Tear | Active comparator | Other: Platelet Poor Plasma Tear Drops |
| Platelet Rich Plasma Tears | Experimental | Other: Platelet Rich Plasma Tear Drops |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be diagnosed with clinically significant dry eye.
- Subjects have no active ocular disease or allergic conjunctivitis.
- Subjects must not be using any topical ocular medications within two weeks prior to enrollment.
- Subjects must be willing and able to follow instructions.
- Subjects must have voluntarily agreed to participate in the study by signing the statement of informed consent.
Key exclusion criteria (4 listed)
- Is pregnant at the time of enrolment in the study determined by urine pregnancy test.
- Is currently on a course of antibiotics
- Is considered by the Investigator to not be a suitable candidate for participation and are not at risk for glaucoma.
- Is considered by the University of Rochester Transfusion Medicine \& Blood Bank not a suitable candidate for blood donation.
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 |
|---|---|---|
| Platelet Poor Plasma Tear DropsParticipant blood will be drawn and processed by the University of Rochester Transfusion Medicine and Blood Bank. Processing will isolate the platelet free fraction of the blood plasma. After processing, plasma should contain ≤ 5% concentration of white blood cells (WBC), red blood cells (RBC), and platelets when compared to the concentration before processing. | Other | Platelet Poor Plasma Tear |
| Platelet Rich Plasma Tear DropsParticipant blood will be drawn and processed by the University of Rochester Transfusion Medicine and Blood Bank. Processing will isolate the platelet fraction of the blood plasma. After processing, plasma should contain ≤ 5% concentration of WBC and RBC and 100 x 10³ μl or ≥ 50% recovery of platelets when compared to the pre-platelet count. | Other | Platelet Rich Plasma Tears |
Primary outcome
Mean change in acuity
Time frame: baseline to 3 months
Acuity will be measured using a Shack-Hartmann Wavefront Sensor. Subjects will be seated in front of the wavefront sensor. They will be asked to blink naturally fixate on the laser spot throughout the measurement protocol. While subjects fixate, the wavefront sensor delivers a brief flash of light to the subjects' retina. The light reflected out of the subjects' eye is collected to obtain measurements of wavefront aberrations of the eye. For optical quality assessments the measurements of wavefront aberrations will be acquired along the line-of-sight. The wavefront data acquired from the wavefront sensor will be described by Zernike coefficients, the most popular mathematical way to represent the ocular aberrations.
Mean change in breakup pattern to appear
Time frame: baseline to 3 months
This will be measured using a Placido Disk. The subject places their chin on a chin rest and look into the disk system. The system uses an incandescent or broad-band area LED for illumination.
Mean change in lipid coverage of the cornea with blinking
Time frame: baseline to 3 months
This will be measured using a Ellipsometer/Tearscope. This instrument uses a modified slit-lamp head restraint and an imaging system to visualize the surface of the subject's cornea. Structurally the system is a clinical slit-lamp system. However, the system uses an electronic camera instead of a human observer. The illumination system uses a diffuse ring illuminator instead of a slit-lamp. The data from this instrument identifies changes in the lipid thickness and the refractive index over the cornea.
Mean change in consistency of lipid compensation
Time frame: baseline to 3 months
This will be measured using a Ellipsometer/Tearscope. This instrument uses a modified slit-lamp head restraint and an imaging system to visualize the surface of the subject's cornea. Structurally the system is a clinical slit-lamp system. However, the system uses an electronic camera instead of a human observer. The illumination system uses a diffuse ring illuminator instead of a slit-lamp. The data from this instrument identifies changes in the lipid thickness and the refractive index over the cornea.
Mean change in temperature over the optical service
Time frame: baseline to 3 months
This will be measured using a Thermal Imaging System. A thermal imaging system will be used to provide spatially-resolved thermal maps of the subject's eyes and face adjacent to the eyes. This camera system is non-invasive and is mounted on a tripod about 12" from the subject's eyes. It images the heat that is emitted by the subject at frame rates from 2 to 10 Hz. The camera displays a spatially resolved map (approximately 0.2 x 0.2 mm pixel size) of the ocular surface temperature. IR detection is a convenient tool for instantaneous temperature measurement of the ocular surface and allows monitoring of time course change as well.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- 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.
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 Platelet Poor Plasma Tear Drops and Platelet Rich Plasma Tear Drops in people with Dry Eye Syndromes, run by University of Rochester 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 6 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: withdrawn, as of the sponsor's last update on 16 Jul 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean change in acuity (time frame: baseline to 3 months). The study lists 5 primary outcomes in all. 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 16 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.