Dry Eye Disease (DED)Phase 4BLINKNCT07529899
Evaluate the Efficacy and Safety of Amnion Membrane Disc Allograft vs Standard of Care in Participants With Dry Eye Disease
A Phase 4 study testing Lyophilized Amnion Membrane Disc Allograft in people with Dry Eye Disease (DED), run by Cellution Biologics.
Trial summary
To evaluate the efficacy of Lyophilized Human Amnion Membrane Disc in reducing corneal epithelial damage as measured by the Lexitas Modified National Eye Institute (NEI) Grading Scale for Corneal Fluorescein Staining. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- Lyophilized Amnion Membrane Disc Allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2027
- Phase
- Phase 4
- 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
- 18 years of age or older.
- Corneal Fluorescein Staining (CFS) Modified NEI grade \> 15 in the study eye.
- Distance best corrected visual acuity better than 20/60 Snellen equivalent in each eye
- Participant failed at least one conservative therapy (artificial tears or topical lubrication) in the previous six months.
- Participant must be able to follow study instructions, with the intention of completing all required visits
- Participant must agree to attend the study visits required by the protocol.
- Participant must be able and willing to complete follow-up.
- Participant must be willing and able to participate in the informed consent process.
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 19Show fewer
- History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK
- Presence of cicatricial ocular surface diseases
- History of procedures listed in 6.7.1 within the specified washout period
- CONFIDENTIAL
- Version No. 1 Version Date 06APR2026
- Page PAGE 67 of NUMPAGES 67
- VERSION 1.0 CELLUTION BIOLOGICS INC. 06 APRIL 2026
- History or use of any medications listed in 6.7.2 within the specified washout period
- Ophthalmic use of amniotic membrane in the past 90 days.
- Participants of childbearing potential who are pregnant, considering becoming pregnant within the next 6 months, and/or are unwilling to utilize an appropriate form of contraception.
- Medical or psychological condition that, in the opinion of the investigator, may interfere with study.
- Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
- Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Amnion Membrane Disc Allograft Versus Standard of Care in Participants With Moderate to Severe Dry Eye Disease
To evaluate the efficacy of Lyophilized Human Amnion Membrane Disc in reducing corneal epithelial damage as measured by the Lexitas Modified National Eye Institute (NEI) Grading Scale for Corneal Fluorescein Staining.
Read the detailed description
Dry Eye Disease (DED) is a chronic, progressive inflammatory multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film. It is accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. DED creates a vicious cycle of ocular surface inflammation and damage. Beyond simple 'dryness', DED is recognized as a chronic, potentially progressive condition that can lead to significant visual impairment, corneal scarring, and a diminished quality of life (QoL) comparable to moderate-to-severe angina or dialysis.
While standard therapies (lubricants, anti-inflammatory agents) manage symptoms, many patients suffer from refractory epithelial defects and keratitis. Human Amniotic Membrane (HAM) has been shown to possess anti-inflammatory, anti-scarring, and epithelial-promoting properties. The Human Amniotic Membrane (HAM) is the innermost layer of the placenta. It is uniquely suited for ocular surface reconstruction due to its complex biological scaffold.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Standard of Care (SOC), Lyophilized Amnion Membrane Disc Allograft
- Keywords
- Dry Eye
- 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.
Standard of Care (SOC)Procedure or surgery
Standard of care is to perform eye cleansing with sterile saline, application of one drop of Ofloxacin prophylactically to eye, application of topical anesthetic, application of bandage lens to eye, application of drops of saline as needed to ensure hydration, taping eye partially shut and continuation of preservative free topical lubricating drops.
Lyophilized Amnion Membrane Disc AllograftOther
Lyophilized Amnion Membrane Disc Allograft derived from donated human tissues.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, application of Ofloxacin, topical anesthetic and bandage). Receives: Other: Lyophilized Amnion Membrane Disc Allograft |
| FD-AM + SoC | Experimental | Participants with dye eye disease will receive treatment with a Freeze-Dried Amnionic Membrane product and treatment with standard of care (cleaning, application of Ofloxacin, topical anesthetic and bandage). Receives: Procedure: Standard of Care (SOC); Other: Lyophilized Amnion Membrane Disc Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Epithelial Damage
Evaluate the change of corneal epithelial damage as measured by the Lexitas Modified National Eye Institute (NEI) Grading Scale for Corneal Fluorescein Staining.
Measured: 6-8 weeks
Secondary outcomes (2)
Patient Reported Symptoms
Evaluate patient reported symptoms.
Measured: 6-8 weeks
Stability of Tear Film
Assess the stability of the tear film
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Change in company strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellution Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Research Director, Study director, Cellution Biologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529899
- Sponsor's protocol ID
- CELLBIO-2026-003
- Acronym
- BLINK
- Status last verified
- Aug 2026
- First submitted
- 8 Apr 2026
- Last updated
- 27 Aug 2026
- Results posted
- 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Amnion Membrane Disc Allograft Versus Standard of Care in Participants With Moderate to Severe Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07529899
- Acronym / sponsor ID
- BLINK / CELLBIO-2026-003
- Conditions
- Dry Eye Disease (DED)
- Keywords
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in company strategy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cellution BiologicsIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Apr 2026 (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.
To evaluate the efficacy of Lyophilized Human Amnion Membrane Disc in reducing corneal epithelial damage as measured by the Lexitas Modified National Eye Institute (NEI) Grading Scale for Corneal Fluorescein Staining.
Detailed description
Dry Eye Disease (DED) is a chronic, progressive inflammatory multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film. It is accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. DED creates a vicious cycle of ocular surface inflammation and damage. Beyond simple 'dryness', DED is recognized as a chronic, potentially progressive condition that can lead to significant visual impairment, corneal scarring, and a diminished quality of life (QoL) comparable to moderate-to-severe angina or dialysis.
While standard therapies (lubricants, anti-inflammatory agents) manage symptoms, many patients suffer from refractory epithelial defects and keratitis. Human Amniotic Membrane (HAM) has been shown to possess anti-inflammatory, anti-scarring, and epithelial-promoting properties. The Human Amniotic Membrane (HAM) is the innermost layer of the placenta. It is uniquely suited for ocular surface reconstruction due to its complex biological scaffold.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Lyophilized Amnion Membrane Disc AllograftBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, application of Ofloxacin, topical anesthetic and bandage). |
| FD-AM + SoC | Experimental | Procedure: Standard of Care (SOC), Other: Lyophilized Amnion Membrane Disc AllograftParticipants with dye eye disease will receive treatment with a Freeze-Dried Amnionic Membrane product and treatment with standard of care (cleaning, application of Ofloxacin, topical anesthetic and bandage). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older.
- Corneal Fluorescein Staining (CFS) Modified NEI grade \> 15 in the study eye.
- Distance best corrected visual acuity better than 20/60 Snellen equivalent in each eye
- Participant failed at least one conservative therapy (artificial tears or topical lubrication) in the previous six months.
- Participant must be able to follow study instructions, with the intention of completing all required visits
Key exclusion criteria (19 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 |
|---|---|---|
| Standard of Care (SOC)Standard of care is to perform eye cleansing with sterile saline, application of one drop of Ofloxacin prophylactically to eye, application of topical anesthetic, application of bandage lens to eye, application of drops of saline as needed to ensure hydration, taping eye partially shut and continuation of preservative free topical lubricating drops. | Procedure or surgery | FD-AM + SoC |
| Lyophilized Amnion Membrane Disc AllograftLyophilized Amnion Membrane Disc Allograft derived from donated human tissues. | Other | FD-AM + SoC, Standard of Care |
Primary outcome
Corneal Epithelial Damage
Time frame: 6-8 weeks
Evaluate the change of corneal epithelial damage as measured by the Lexitas Modified National Eye Institute (NEI) Grading Scale for Corneal Fluorescein Staining.
2 secondary outcomes
Patient Reported Symptoms
Time frame: 6-8 weeks
Stability of Tear Film
Time frame: 6-8 weeks
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 27 Aug 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.
Research Director study director
Cellution Biologics
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lyophilized Amnion Membrane Disc Allograft in people with Dry Eye Disease (DED), run by Cellution Biologics.
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 8 inclusion and 19 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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Corneal Epithelial Damage (time frame: 6-8 weeks). 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 27 Aug 2026.