ClinicalTrials.gg
RecruitingNCT07217678Updated Mar 5, 2026

Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use

A Phase 4 interventional study of Durysta, Bimatoprost Intracameral Implant 10 µg in Glaucoma, Open-Angle Glaucoma and Ocular Hypertension, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.

Primary conditionGlaucoma, Open-AngleRegistry: GlaucomaReclassifiedWhy we changed it
Registry
Glaucoma — the first condition term the registry derived for this study.
ClinicalTrials.gg
Glaucoma, Open-Angle
Why
  1. The study's listed conditions name Glaucoma, Open-Angle, a narrower term within Glaucoma.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Miami · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 348 studies in Glaucoma, Open-Angle with a site in United States — 49 open to participants now, 67 under way, 5 of them phase 3. Glaucoma, Open-Angle · United States.

Planned enrollment
242nd of 279
20 · median 84
Started
2026
with 18 others
Phase 4
36 of 348
9 open now
Primary completion
2028-01
later than 48 of 66 live
Registered
325th of 348
by date

Among the 348 studies in Glaucoma, Open-Angle with a site in United States, this one is the 242nd largest by planned enrollment of the 279 interventional ones that give a count, is one of 19 that started in 2026, is one of 36 in phase 4, reaches primary completion later than 48 of the 66 other live ones, and was the 325th registered.

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 116 are open to participants now.

Browse Glaucoma, Open-Angle studies →

Open to participants now

49 of the 348 studies in Glaucoma, Open-Angle with a site in United States are open now. Recruiting first, the newest first:

43 more — sign in →

All 49 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 83 Glaucoma, Open-Angle studies recruiting now, 64 (77%) set no upper age limit and 5 (6%) stop at 75 or younger; 5 take children under 18; 11 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 348 studies in Glaucoma, Open-Angle with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Glaucoma
  • Open-Angle Glaucoma
  • Ocular Hypertension
  • Glaucoma Suspect

Browse trials for

04

In context

Glaucoma, Open-Angle Reclassified

924 studies on the registry are indexed under Glaucoma, Open-Angle; 116 are open to participants now.

This study's planned enrollment of 20 is below the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

University of Miami is the lead sponsor of 842 studies on the registry; 166 are open to participants now.

Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.

Compared within Glaucoma, Open-Angle, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Glaucoma. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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., , cyclosporine, lifitegrast, or antihistamines)
  • Use of preservative-free hypotensive medications
  • Any clinical 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

06

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Durysta

    Participants will receive a one-time intracameral administration of Durysta - bimatoprost 10mcg

    Drug: Durysta, Bimatoprost Intracameral Implant 10 µg

Interventions

  • DrugDurysta, Bimatoprost Intracameral Implant 10 µg

    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.

07

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, post-injection 1 month, post-injection 3 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, post-injection 1 month, post-injection 3 months

  2. 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.

    Time frame: Baseline, post-injection 1 month, post-injection 3 months

  3. 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.

    Time frame: Baseline, post-injection 1 month, post-injection 3 months

08

Study locations

1 of 1 sites recruiting
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Jan 2028, 23 months after the start.

Of 45 phase 4 interventional studies under Glaucoma, Open-Angle, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 37. This study's planned 23 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2025
First posted
Oct 16, 2025
StartActual
Feb 9, 2026
Primary completionEst.
Jan 31, 2028
CompletionEst.
Jan 31, 2028
Last update
Mar 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07217678
Collaborators
AbbVie
Responsible party
Swarup Swaminathan (Associate Professor of Ophthalmology, University of Miami) — Principal investigator
First posted
Oct 16, 2025
Start date
Feb 9, 2026
Primary completion
Jan 31, 2028 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Mar 5, 2026

Study contacts

Javier Paredes, BA, MBA
Contact
jxp2537@med.miami.edu
305-326-6387
Monica Arango, BA
Contact
mrarango@med.miami.edu
305-326-6351
Swarup S Swaminathan, MD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion