GlaucomaPhase 4NCT07217678
Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
A Phase 4 study testing Durysta, Bimatoprost Intracameral Implant 10 µg in people with Glaucoma and Open-Angle Glaucoma, run by University of Miami at 1 site in United States.
Trial summary
The objective of this study is to evaluate whether reduction in topical medication with the injection of a sustained release capsule (Durysta) leads to a reduction in ocular surface inflammation, indicated by levels of caspase-1, an inflammatory biomarker. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Durysta, Bimatoprost Intracameral Implant 10 µg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2026to 31 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Eye with open-angle glaucoma or suspected of open-angle glaucoma
- Pseudophakic in eye of interest with Shafer grading ≥3
- ≤ 3 daily applications of topical glaucoma medications for ≥6 months (of which one is a nightly preserved PGA)
- Good adherence to medication regimen - screening questions to be asked of potential subject:
- In the last month, what percentage of the time would you estimate missing the application of drops? (Must be ≤20%)
- When was the last administration? (Last dose must have been within last 24 hours)
- Presence of punctate epithelial erosions in the cornea (NEI scale > 3)
Who cannot join
- Retinal disease (e.g., wet age-related macular degeneration, proliferative diabetic retinopathy, central retinal vein occlusion)
- Use of topical or systemic immunosuppressor or immunomodulator drug (e.g., steroids, cyclosporine, lifitegrast, or antihistamines)
- Use of preservative-free hypotensive medications
- Any clinical contraindications to receiving intracameral bimatoprost implantation
- History of recurrent conjunctivitis (e.g., allergic or atopic conjunctivitis)
- History of partial or full corneal transplant
- History of ophthalmic surgery (intraocular or tarsus-involving oculoplastic procedures) within last 6 months
- History of subconjunctival glaucoma surgery (i.e., trabeculectomy, aqueous shunt, Xen implant) within last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bascom Palmer Eye Institute
Miami, Florida, 33134
Javier Paredes, BA, MBA, 305-326-6387, jxp2537@med.miami.edu
Monica Arango, BA, 305-326-6351, mrarango@med.miami.edu
About this study
The objective of this study is to evaluate whether reduction in topical medication with the injection of a sustained release capsule (Durysta) leads to a reduction in ocular surface inflammation, indicated by levels of caspase-1, an inflammatory biomarker.
- Conditions
- Glaucoma, Open-Angle Glaucoma, Ocular Hypertension, Glaucoma Suspect
- Being tested
- Durysta, Bimatoprost Intracameral Implant 10 µg
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durysta, Bimatoprost Intracameral Implant 10 µgDrug
Participants in this arm will receive a one-time injection of Durysta (intracameral bimatoprost 10mcg). Participants will be followed by a total of 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Durysta | Experimental | Participants will receive a one-time intracameral administration of Durysta - bimatoprost 10mcg Receives: Drug: Durysta, Bimatoprost Intracameral Implant 10 µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Caspase-1 mRNA Expression Following Durysta Injection
The primary outcome is evaluating whether the level of caspase-1 from the ocular surface changes after the Durysta injection when the number of topical medications is reduced. Higher values indicate more inflammation, while lower values indicate less information and a more stable ocular surface. The Caspase-1 level will be measured using RT-PCR.
Measured: Baseline, post-injection 1 month, post-injection 3 months
Secondary outcomes (3)
Change in Corneal Sensitivity Following Durysta Injection
Change in corneal tactile sensitivity from measured using a non-contact esthesiometer (in sensitivity units). Greater sensitivity values indicate less ocular surface dysfunction; lower values reflect reduced sensitivity and potential surface.
Measured: Baseline, post-injection 1 month, post-injection 3 months
Change in Ocular Pain Symptoms via Visual Analog Scale (VAS)
Change in patient-reported ocular pain symptoms from post-Durysta injection, assessed using a Visual Analog Scale (VAS). VAS scores range from 1 to 10, where higher scores indicate more severe pain and lower scores reflect minimal discomfort.
Measured: Baseline, post-injection 1 month, post-injection 3 months
Change in Corneal Staining Score Using the National Eye Institute (NEI) Grading System
Change in corneal staining score post-Durysta injection, assessed using the National Eye Institute (NEI) grading system. This system evaluates five corneal regions-central, temporal, superior, nasal, and inferior-with each region scored from 0 to 3 based on fluorescein staining intensity. The total score ranges from 0 (no staining) to 15 (diffuse staining across all regions). Lower scores indicate improved ocular surface integrity and reduced epithelial damage; higher scores reflect more extensive surface compromise.
Measured: Baseline, post-injection 1 month, post-injection 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 Oct 2025
- Study start9 Feb 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, Swarup Swaminathan, University of Miami
- Investigators
- Swarup S Swaminathan, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217678
- Sponsor's protocol ID
- 20240111
- Status last verified
- Mar 2026
- First submitted
- 14 Oct 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
- ClinicalTrials.gov ID
- NCT07217678
- Acronym / sponsor ID
- 20240111
- Conditions
- Glaucoma, Open-Angle Glaucoma, Ocular Hypertension, Glaucoma Suspect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 16 Oct 2025 (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 objective of this study is to evaluate whether reduction in topical medication with the injection of a sustained release capsule (Durysta) leads to a reduction in ocular surface inflammation, indicated by levels of caspase-1, an inflammatory biomarker.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durysta | Experimental | Drug: Durysta, Bimatoprost Intracameral Implant 10 µgParticipants will receive a one-time intracameral administration of Durysta - bimatoprost 10mcg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eye with open-angle glaucoma or suspected of open-angle glaucoma
- Pseudophakic in eye of interest with Shafer grading ≥3
- ≤ 3 daily applications of topical glaucoma medications for ≥6 months (of which one is a nightly preserved PGA)
- Good adherence to medication regimen - screening questions to be asked of potential subject:
- In the last month, what percentage of the time would you estimate missing the application of drops? (Must be ≤20%)
Key exclusion criteria (8 listed)
- Retinal disease (e.g., wet age-related macular degeneration, proliferative diabetic retinopathy, central retinal vein occlusion)
- Use of topical or systemic immunosuppressor or immunomodulator drug (e.g., steroids, cyclosporine, lifitegrast, or antihistamines)
- Use of preservative-free hypotensive medications
- Any clinical contraindications to receiving intracameral bimatoprost implantation
- History of recurrent conjunctivitis (e.g., allergic or atopic conjunctivitis)
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 |
|---|---|---|
| Durysta, Bimatoprost Intracameral Implant 10 µgParticipants in this arm will receive a one-time injection of Durysta (intracameral bimatoprost 10mcg). Participants will be followed by a total of 3 months. | Drug | Durysta |
Primary outcome
Change in Caspase-1 mRNA Expression Following Durysta Injection
Time frame: Baseline, post-injection 1 month, post-injection 3 months
The primary outcome is evaluating whether the level of caspase-1 from the ocular surface changes after the Durysta injection when the number of topical medications is reduced. Higher values indicate more inflammation, while lower values indicate less information and a more stable ocular surface. The Caspase-1 level will be measured using RT-PCR.
3 secondary outcomes
Change in Corneal Sensitivity Following Durysta Injection
Time frame: Baseline, post-injection 1 month, post-injection 3 months
Change in Ocular Pain Symptoms via Visual Analog Scale (VAS)
Time frame: Baseline, post-injection 1 month, post-injection 3 months
Change in Corneal Staining Score Using the National Eye Institute (NEI) Grading System
Time frame: Baseline, post-injection 1 month, post-injection 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 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.
Swarup S Swaminathan, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Durysta, Bimatoprost Intracameral Implant 10 µg in people with Glaucoma and Open-Angle Glaucoma, run by University of Miami 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Mar 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javier Paredes, BA, MBA (305-326-6387, jxp2537@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Caspase-1 mRNA Expression Following Durysta Injection (time frame: Baseline, post-injection 1 month, post-injection 3 months). 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 Mar 2026.