A Phase 1/2 interventional study of Dextenza 0.4Mg Ophthalmic Insert and topical prednisolone acetate 1% (PredForte) eye drops in Keratoconus, sponsored by Maanasa Indaram, MD. Enrolling by invitation at 3 sites in United States. Open to participants aged 13 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Maanasa Indaram, MD · Phase 1/2, Interventional, and Treatment
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.
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 205 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →This is the only study on the registry with Maanasa Indaram, MD as lead sponsor.
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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:
Exclusion Criteria:
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Dextenza 0.4Mg Ophthalmic Insert
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.
Drug: topical prednisolone acetate 1% (PredForte) eye drops
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.
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.
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)
Time frame: 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.
Time frame: 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.
Time frame: 6 months (180 days)
Infection
Adverse event end point: Postoperative infection as measured at any visit.
Time frame: 6 months (180 days)
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months (180 days)
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Dec 2026, 20 months after the start.
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