Cataract
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGDexycu intracameral dexamethasone
To evaluate the safety and ocular efficacy of Dexycu.
DRUGPrednisolone Acetate
To evaluate the safety and ocular efficacy, and patient acceptance of post cataract surgery drug treatment regimen that minimizes topical medications.
Sponsors
Research Insight LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Only the participants will be masked.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A male or female in good general health, greater than 18 years of age at time of screening. * Must be able to comprehend and willing to give informed consent. * Woman of child-bearing potential must not be pregnant or lactating. * Subject has availability, willingness, and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled study visits. * Subject with cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned. * Subject with an OCT of the macula in both eyes that demonstrates no significant pathology.
Exclusion criteria
* Subject with any signs of intraocular inflammation in either eye at screening. * Subject with a known sensitivity to any of the study medications. * Subject with only one eye with potentially good vision. * Subject that has undergone prior intraocular surgery in the scheduled surgical eye within the last 6 months or laser surgery within three months prior to screening. * Subject with pupil abnormalities. * Subject with corneal abnormalities. * Subject with a history of chronic/recurrent inflammatory eye disease in either eye. * Subject with uncontrolled glaucoma. * Subject expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period. * Subject who requires use of systemic or ocular medications that may affect vision, ocular inflammation, or pain. * Subject with an acute or chronic disease or illness that would increase risk or confound study results, e.g. autoimmune disease, etc. * Subject with an uncontrolled systemic disease. * Subject with poorly-controlled diabetes. * Subject currently participating or has participated in another clinical trial within 30 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient preference for medication protocol in 30 randomized subjects | Day 28 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication cost in 30 randomized subjects | Day 28 | Cost of medications to the patient (patient-reported) |
| Subject evaluation of postop ocular pain in 30 randomized subjects | Day 28 | Study subject evaluation of post-op ocular pain. |
| Summed Ocular Inflammation Score in 30 randomized subjects | Day 28 | Summed Ocular Inflammation Score (sum of the mean anterior chamber cells and anterior flare score) |
Countries
United States
Outcome results
None listed