KeratoconusPhase 1/2NCT06235567
Dextenza Versus Topical Steroid Eye Drops for Postoperative Management Following Corneal Crosslinking
A Phase 1/2 study testing Dextenza 0.4Mg Ophthalmic Insert and topical prednisolone acetate 1% (PredForte) eye drops in people with Keratoconus, run by Maanasa Indaram, MD at 3 sites in United States.
Trial summary
This study aims to compare the use of Dextenza, an FDA-approved intracanilular drug-eluting insert that is designed to deliver a tapered dose of dexamethasone to the ocular surface for 30 days, to the standard of care, or the use of a month-long topical prednisolone acetate 1% (PredForte) eye drops starting from four… Read more about this study
- Who is it for?
- Ages 13 to 64 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Dextenza 0.4Mg Ophthalmic Insert and topical prednisolone acetate 1% (PredForte) eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Apr 2025to Jul 2027
- Phase
- Phase 1/2
- 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 13 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The study will enroll patients age 13 and up with progressive keratoconus (KCN) who are scheduled for bilateral epithelial off corneal collagen cross-linking (CXL) with Photrexa. A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- Progressive keratoconus as defined by increasing astigmatism and/or keratometry on corneal topography or tomography or increasing cylindrical error on refraction
- Patients requiring general anesthetic for the procedure
- Preoperative central corneal thickness of >= 400 microns
Who cannot join
- History of acute hydrops in treated eye
- History of pre-existing severe corneal scarring in the treated eye
- History of pre-existing glaucoma in the treated eye
- History of or pharmaceutical treatment of glaucoma or ocular hypertension and history or current spikes in intraocular pressure (IOP) in either eye.
- History of pre-existing ocular inflammation or infection (conjunctivitis, keratitis, uveitis, or retinitis) in treated eye
- Active infectious systemic disease
Show all 13Show fewer
- Obstructed nasolacrimal duct in the study eye(s)
- Patients with a nasolacrimal duct smaller than 0.4 mm or greater than or equal to 1.0 mm.
- Patients with stenosis to the location where the insert will be placed should be excluded from the study, as the study team would not engage in surgical procedures to expand or surgically correct that region
- Hypersensitivity to dexamethasone
- Patients being treated with immunomodulating agents in the study eye(s)
- Patients being treated with immunosuppressants and/or oral steroids
- Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Mission Bay Hospital
San Francisco, California, 94158
UCSF Pediatric Ophthalmology
San Francisco, California, 94158
Wayne and Gladys Center for Vision
San Francisco, California, 94158
About this study
Official title: Comparison of Intracanalicular Steroid-eluting Insert (Dextenza) to Topical Steroid Eye Drops for the Postoperative Management of Corneal Collagen Crosslinking
This study aims to compare the use of Dextenza, an FDA-approved intracanilular drug-eluting insert that is designed to deliver a tapered dose of dexamethasone to the ocular surface for 30 days, to the standard of care, or the use of a month-long topical prednisolone acetate 1% (PredForte) eye drops starting from four times daily. Following treatment, Dextenza resorbs and exits the nasolacrimal system without the need for removal. Three prior phase 3 clinical trials have demonstrated that Dextenza is equally efficacious to a month-long topical Pred Forte taper in the treatment of postoperative inflammation following cataract surgery. This proposed study strives to demonstrate the non-inferiority of using Dextenza to treat postoperative inflammation following corneal collagen crosslinking compared to standard of care eye drops in a randomized trial. By demonstrating Dextenza's non-inferiority to treatment postoperative inflammation, the investigators hope to provide an alternative modality of treatment to patients who are unable to cooperate with or tolerate postoperative topical eye drop regimens, allowing for improved adherence to necessary therapy and thus improved postoperative outcomes.
- Conditions
- Keratoconus
- Being tested
- Dextenza 0.4Mg Ophthalmic Insert, topical prednisolone acetate 1% (PredForte) eye drops
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextenza 0.4Mg Ophthalmic InsertDrug
This insert allows for sustained release of dexamethasone onto the ocular surface over a period of 28 days. It requires a single application and eliminates the potential for noncompliance, difficulty in administration and poor accuracy. Dextenza has been FDA approved for post-operative pain and inflammation following ophthalmic surgery. The pivotal trials included patients undergoing cataract surgery, not CXL surgery. In addition, the age range did not include those of pediatric age.
topical prednisolone acetate 1% (PredForte) eye dropsDrug
The patient will administer the anti-inflammatory steroid drops on the same 4 week post-operative schedule that is commonly used in standard of care. They will do one drop of Pred Forte in the affected eye 4 times a day for a week, 3 times a day for the second week, 2 times a day for the third week, and once a day for the fourth week.
| Study group | Role | What they receive |
|---|---|---|
| Dextenza insert | Experimental | This is a prospective, open-label, single-center, randomized, investigator-sponsored clinical study to compare dexamethasone intracanalicular insert and corticosteroid drops for post-treatment in patients undergoing epithelium-off corneal collagen cross linking surgery. The participant's worse eye will be randomized to one of the two treatments, and the fellow eye will receive the alternate treatment when undergoing the procedure at a subsequent date at least three weeks later. There will be a baseline/screening visit, a surgical/ insertion visit for each eye, and follow up visits over 6 months, for a total of 10 visits per patient.
The study drug, DEXTNZA, is administered during the surgical procedure and the patient does not need to do any additional steps. Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert |
| topical prednisolone acetate 1% (PredForte) eye drops | Active comparator | This is a prospective, open-label, single-center, randomized, investigator-sponsored clinical study to compare dexamethasone intracanalicular insert and corticosteroid drops for post-treatment in patients undergoing epithelium-off corneal collagen cross linking surgery. The participant's worse eye will be randomized to one of the two treatments, and the fellow eye will receive the alternate treatment when undergoing the procedure at a subsequent date at least three weeks later. There will be a baseline/screening visit, a surgical/ insertion visit for each eye, and follow up visits over 6 months, for a total of 10 visits per patient.
The patient will administer the anti-inflammatory steroid drops on the same 4 week post-operative schedule that is commonly used in standard of care. They will do one drop of Pred Forte in the affected eye 4 times a day for a week, 3 times a day for the second week, 2 times a day for the third week, and once a day for the fourth week. Receives: Drug: topical prednisolone acetate 1% (PredForte) eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal haze
Assess the efficacy of the dexamethasone insert compared to corticosteroid drops for post-treatment in patients who have had epithelium-off corneal collagen cross linking procedure.
This will be assessed by
-Postoperative corneal haze as measured by the Physician with a slit lamp biomicroscopy and graded on a scale of 0-4+ (0 = least haze ; 4= most haze)
Measured: 1 months (30 days)
Corneal re-epithelialization
Assess the efficacy of the dexamethasone insert compared to corticosteroid drops for post-treatment in patients who have had epithelium-off corneal collagen cross linking procedure.
This will be assessed by
-Physician measured corneal re-epithelialization after bandage contact lens removal by slit lamp biomicroscopy.
Measured: 6 months (180 days)
Keratometry
Assess the efficacy of the dexamethasone insert compared to corticosteroid drops for post-treatment in patients who have had epithelium-off corneal collagen cross linking procedure.
This will be assessed by
Postoperative keratometry values (diopters) as measured by corneal topography or Pentacam tomography. Comparing the pre- to post- operative values.
Measured: 6 months (180 days)
Infection
Adverse event end point: Postoperative infection as measured at any visit.
Measured: 6 months (180 days)
Secondary outcomes (7)
Comfort
To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by:
- Patient comfort postoperatively as measured by a 0-10 scale and determined by asking the patient (0= no comfort; 10= maximum comfort)
Measured: 6 months (180 days)
Ocular Pain Assessment
To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by:
- Patient pain postoperatively as measured by a 0-10 scale and determined by asking the patient (0= no pain ; 10= maximum pain)
Measured: 6 months (180 days)
Ease of insertion
To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by:
- Physician ease of insertion as measured by a 0-5-point scale (0= easy insertion ; 5= difficult insertion)
Measured: 6 months (180 days)
Comparison of Ophthalmic Medications for Tolerability Questionnaire
To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by:
- Patient's and caregivers' therapy of preference as measured by the Comparison of Ophthalmic Medications for Tolerability Questionnaire (COMTOL)
Measured: 6 months (180 days)
IOP spikes incidence
To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by:
- Incidence of IOP spikes (IOP increased >or = 10mmHg from baseline) measured
Measured: 6 months (180 days)
Anterior segment OCT
To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by:
- Anterior segment OCT findings mean change from baseline
Measured: 6 months (180 days)
Best Corrected Visual Acuity
To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by:
- Best corrected visual acuity mean change from baseline as measured
Measured: 6 months (180 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start11 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For group A, the study drug, DEXTNZA, is administered during the surgical procedure and the patient does not need to do any additional steps. For group B, the patient will administer the anti-inflammatory steroid drops on the same 4 week post-operative schedule that is commonly used in standard of care. They will do one drop of Pred Forte in the affected eye 4 times a day for a week, 3 times a day for the second week, 2 times a day for the third week, and once a day for the fourth week. The fellow eye will receive the alternate treatment when undergoing the procedure at a subsequent date at least 3 weeks following the first eye, and both within 45 days of the screening visit. Day 0 to Day 30 surgery and assessment schedule will be followed twice, once for each eye.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maanasa Indaram, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maanasa Indaram, MD, University of California, San Francisco
- Investigators
- Maanasa Indaram, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235567
- Sponsor's protocol ID
- 23-40498
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2024
- Last updated
- 11 Sep 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intracanalicular Steroid-eluting Insert (Dextenza) to Topical Steroid Eye Drops for the Postoperative Management of Corneal Collagen Crosslinking
- ClinicalTrials.gov ID
- NCT06235567
- Acronym / sponsor ID
- 23-40498
- Conditions
- Keratoconus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maanasa Indaram, MDUniversity, hospital or other
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 1 Feb 2024 (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 study aims to compare the use of Dextenza, an FDA-approved intracanilular drug-eluting insert that is designed to deliver a tapered dose of dexamethasone to the ocular surface for 30 days, to the standard of care, or the use of a month-long topical prednisolone acetate 1% (PredForte) eye drops starting from four times daily. Following treatment, Dextenza resorbs and exits the nasolacrimal system without the need for removal. Three prior phase 3 clinical trials have demonstrated that Dextenza is equally efficacious to a month-long topical Pred Forte taper in the treatment of postoperative inflammation following cataract surgery. This proposed study strives to demonstrate the non-inferiority of using Dextenza to treat postoperative inflammation following corneal collagen crosslinking compared to standard of care eye drops in a randomized trial. By demonstrating Dextenza's non-inferiority to treatment postoperative inflammation, the investigators hope to provide an alternative modality of treatment to patients who are unable to cooperate with or tolerate postoperative topical eye drop regimens, allowing for improved adherence to necessary therapy and thus improved postoperative outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For group A, the study drug, DEXTNZA, is administered during the surgical procedure and the patient does not need to do any additional steps. For group B, the patient will administer the anti-inflammatory steroid drops on the same 4 week post-operative schedule that is commonly used in standard of care. They will do one drop of Pred Forte in the affected eye 4 times a day for a week, 3 times a day for the second week, 2 times a day for the third week, and once a day for the fourth week. The fellow eye will receive the alternate treatment when undergoing the procedure at a subsequent date at least 3 weeks following the first eye, and both within 45 days of the screening visit. Day 0 to Day 30 surgery and assessment schedule will be followed twice, once for each eye.
| Arm | Type | Receives |
|---|---|---|
| Dextenza insert | Experimental | Drug: Dextenza 0.4Mg Ophthalmic InsertThis is a prospective, open-label, single-center, randomized, investigator-sponsored clinical study to compare dexamethasone intracanalicular insert and corticosteroid drops for post-treatment in patients undergoing epithelium-off corneal collagen cross linking surgery. The participant's worse eye will be randomized to one of the two treatments, and the fellow eye will receive the alternate treatment when undergoing the procedure at a subsequent date at least three weeks later. There will be a baseline/screening visit, a surgical/ insertion visit for each eye, and follow up visits over 6 months, for a total of 10 visits per patient. The study drug, DEXTNZA, is administered during the surgical procedure and the patient does not need to do any additional steps. |
| topical prednisolone acetate 1% (PredForte) eye drops | Active comparator | Drug: topical prednisolone acetate 1% (PredForte) eye dropsThis is a prospective, open-label, single-center, randomized, investigator-sponsored clinical study to compare dexamethasone intracanalicular insert and corticosteroid drops for post-treatment in patients undergoing epithelium-off corneal collagen cross linking surgery. The participant's worse eye will be randomized to one of the two treatments, and the fellow eye will receive the alternate treatment when undergoing the procedure at a subsequent date at least three weeks later. There will be a baseline/screening visit, a surgical/ insertion visit for each eye, and follow up visits over 6 months, for a total of 10 visits per patient. The patient will administer the anti-inflammatory steroid drops on the same 4 week post-operative schedule that is commonly used in standard of care. They will do one drop of Pred Forte in the affected eye 4 times a day for a week, 3 times a day for the second week, 2 times a day for the third week, and once a day for the fourth week. |
Who may qualify
- Ages
- 13 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- The study will enroll patients age 13 and up with progressive keratoconus (KCN) who are scheduled for bilateral epithelial off corneal collagen cross-linking (CXL) with Photrexa. A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
Key exclusion criteria (13 listed)
- History of acute hydrops in treated eye
- History of pre-existing severe corneal scarring in the treated eye
- History of pre-existing glaucoma in the treated eye
- History of or pharmaceutical treatment of glaucoma or ocular hypertension and history or current spikes in intraocular pressure (IOP) in either eye.
- History of pre-existing ocular inflammation or infection (conjunctivitis, keratitis, uveitis, or retinitis) in treated eye
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 |
|---|---|---|
| Dextenza 0.4Mg Ophthalmic InsertThis insert allows for sustained release of dexamethasone onto the ocular surface over a period of 28 days. It requires a single application and eliminates the potential for noncompliance, difficulty in administration and poor accuracy. Dextenza has been FDA approved for post-operative pain and inflammation following ophthalmic surgery. The pivotal trials included patients undergoing cataract surgery, not CXL surgery. In addition, the age range did not include those of pediatric age. | Drug | Dextenza insert |
| topical prednisolone acetate 1% (PredForte) eye dropsThe patient will administer the anti-inflammatory steroid drops on the same 4 week post-operative schedule that is commonly used in standard of care. They will do one drop of Pred Forte in the affected eye 4 times a day for a week, 3 times a day for the second week, 2 times a day for the third week, and once a day for the fourth week. | Drug | topical prednisolone acetate 1% (PredForte) eye drops |
Primary outcome
Corneal haze
Time frame: 1 months (30 days)
Assess the efficacy of the dexamethasone insert compared to corticosteroid drops for post-treatment in patients who have had epithelium-off corneal collagen cross linking procedure. This will be assessed by -Postoperative corneal haze as measured by the Physician with a slit lamp biomicroscopy and graded on a scale of 0-4+ (0 = least haze ; 4= most haze)
Corneal re-epithelialization
Time frame: 6 months (180 days)
Assess the efficacy of the dexamethasone insert compared to corticosteroid drops for post-treatment in patients who have had epithelium-off corneal collagen cross linking procedure. This will be assessed by -Physician measured corneal re-epithelialization after bandage contact lens removal by slit lamp biomicroscopy.
Keratometry
Time frame: 6 months (180 days)
Assess the efficacy of the dexamethasone insert compared to corticosteroid drops for post-treatment in patients who have had epithelium-off corneal collagen cross linking procedure. This will be assessed by Postoperative keratometry values (diopters) as measured by corneal topography or Pentacam tomography. Comparing the pre- to post- operative values.
Infection
Time frame: 6 months (180 days)
Adverse event end point: Postoperative infection as measured at any visit.
7 secondary outcomes
Comfort
Time frame: 6 months (180 days)
Ocular Pain Assessment
Time frame: 6 months (180 days)
Ease of insertion
Time frame: 6 months (180 days)
Comparison of Ophthalmic Medications for Tolerability Questionnaire
Time frame: 6 months (180 days)
IOP spikes incidence
Time frame: 6 months (180 days)
Anterior segment OCT
Time frame: 6 months (180 days)
Best Corrected Visual Acuity
Time frame: 6 months (180 days)
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 11 Sep 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.
Maanasa Indaram, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dextenza 0.4Mg Ophthalmic Insert and topical prednisolone acetate 1% (PredForte) eye drops in people with Keratoconus, run by Maanasa Indaram, MD at 3 sites 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 4 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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 haze (time frame: 1 months (30 days)). The study lists 4 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 11 Sep 2026.