Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a post-approval, open-label, randomized, self-controlled prospective clinical study to evaluate the safety and ocular efficacy of Dexycu in controlling postoperative ocular pain and inflammation associated with cataract surgery.
On initial consultation, each study subject will be randomized by a table in the possession of investigators to receive one of two treatment groups, either experimental or control in the first eye. The second eye will undergo cataract surgery approximately 2 weeks later and will be treated with the other treatment group:
Dexycu Group: A total of 30 study subjects will have Dexycu intracameral dexamethasone placed in their scheduled surgical eye at the time of surgery and will receive 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure. They will take Prolensa each day after surgery for 4 weeks.
Control Group: A total of 30 study subjects will receive topical moxifloxacin 0.5% four times per day 1 day prior to surgery and for ten days postoperatively, Prolensa every day 1 day prior to surgery and for 4 weeks postoperatively, and prednisolone acetate 1.0% four times per day starting at the conclusion of cataract surgery for 2 weeks and twice per day for 2 weeks in their scheduled surgical eye.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexycu Group | Active Comparator | A total of 30 study subjects (30 eyes) will have Dexycu intracameral dexamethasone placed in their scheduled surgical eye at the time of surgery and will receive 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure. They will take Prolensa qd after surgery for 4 weeks. |
|
| Control Group | Active Comparator | A total of 30 study subjects (30 eyes) will receive topical moxifloxacin 0.5% qid 1 day prior to surgery and for ten days postoperatively, Prolensa qd 1 day prior to surgery and for 4 weeks postoperatively, and prednisolone acetate 1.0% qid starting at the conclusion of cataract surgery for 2 weeks and bid for 2 weeks in their scheduled surgical eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexycu intracameral dexamethasone | Drug | To evaluate the safety and ocular efficacy of Dexycu. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient preference for medication protocol in 30 randomized subjects | Patient preference for medication protocol between the two eyes, as reported based on the question, "Thinking about your overall experience taking medications in each eye after surgery, which eye did you prefer? Questionnaire | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject evaluation of postop ocular pain in 30 randomized subjects | Study subject evaluation of post-op ocular pain. | Day 28 |
| Summed Ocular Inflammation Score in 30 randomized subjects | Summed Ocular Inflammation Score (sum of the mean anterior chamber cells and anterior flare score) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Hovanesian, MD | Research Insight LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Eye Associates | Laguna Hills | California | 92653 | United States | ||
| Ophthalmic Consultants of Long Island |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35067660 | Derived | Hovanesian JA, Donnenfeld ED. Intracameral dexamethasone 9% vs prednisolone acetate 1% in controlling postoperative pain and inflammation in patients undergoing cataract surgery. J Cataract Refract Surg. 2022 Aug 1;48(8):906-911. doi: 10.1097/j.jcrs.0000000000000887. Epub 2022 Jan 18. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C053083 | bromfenac |
| C009935 | prednisolone acetate |
Not provided
Not provided
Not provided
Each study subject will be randomized by a table in the possession of investigators to receive one of 2 treatment groups, either experimental or control in the first eye. The second eye will undergo cataract surgery approximately 2 weeks later and will be treated with the other treatment group:
Dexycu Group:A total of 30 study subjects will have Dexycu intracameral dexamethasone placed in their scheduled surgical eye at the time of surgery and will receive 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure. They will take Prolensa each day after surgery for 4 weeks.
Control Group:A total of 30 study subjects will receive topical moxifloxacin 0.5% 4 times per day 1 day prior to surgery and for 10 days postoperatively, Prolensa every day 1 day prior to surgery and for 4 weeks postoperatively, and prednisolone acetate 1% four times per day starting at the conclusion of cataract surgery for 2 weeks and twice per day for 2 weeks in their scheduled surgical eye.
Not provided
Not provided
Only the participants will be masked.
| Prednisolone Acetate | Drug | To evaluate the safety and ocular efficacy, and patient acceptance of post cataract surgery drug treatment regimen that minimizes topical medications. |
|
| Day 28 |
| Medication cost in 30 randomized subjects | Cost of medications to the patient (patient-reported) | Day 28 |
| Garden City |
| New York |
| 11530 |
| United States |