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
| Name | Class |
|---|---|
| The Eye Associates | OTHER |
Not provided
Not provided
Not provided
This is a multicenter, 2-arm, randomized, prospective study of patients slated for bilateral cataract extraction. One eye will be randomized to the Study Arm, and the fellow eye will be randomized to the Control Arm.
For the control arm interventions:
Preoperatively, the Control Arm (control eye) will self-administer a regimen of ketorolac four times daily (QID) x 1 day and moxifloxacin drops three times daily (TID) x 1 day before surgery. On the Day of Surgery, eyes in the Control Arm will receive in-office drops administered by study staff according to the following schedule:
Eyes in the Control Arm will then self-administer the following postoperative interventions: ketorolac drops QID x 1 month, prednisolone acetate tapering QID x1 week, TID x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week; and moxifloxacin drops TID x 1 week.
For the study arm interventions:
Eyes will receive in-office drops on the Day of Surgery administered by study staff according to the following schedule:
Eyes in the Study Arm will be treated with the following intraoperative interventions: intracameral phenylephrine 1.0%/ketorolac 0.3%, intracameral moxifloxacin, and subconjunctival triamcinolone acetonide.
The following study assessments will take place for all subjects:
Visual acuity measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart (pinhole visual acuity [VA] or best corrected visual acuity [BCVA])
Eyes in the Study Arm will also receive in-office drops administered by study staff at the end of the 1-day visit: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate.
Rescue therapy for postoperative inflammation will be allowed for Study Arm participants, if necessary, at the discretion of the evaluating physician and will consist of prednisolone acetate QID (taper also at the discretion of the evaluating physician).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm (OMIDRIA) | Experimental |
Intraoperative interventions: intracameral phenylephrine {Sudafed} 1.0%/ketorolac 0.3%, {OMIDRIA} intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10 mg/mL) {Kenalog}. In-office drops administered by study staff at the end of the 1-day visit: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%). Rescue therapy will be allowed, if necessary, at the discretion of the evaluating physician and will consist of prednisolone acetate (1%) QID (taper also at the discretion of the evaluating physician). |
|
| Control Arm (Standard of Care) | Active Comparator | Self-administration of: Ketorolac (0.5%) {Toradol} four times daily (QID) x 1 day and moxifloxacin (0.5%) {Avelox} drops three times daily (TID) x 1 day before SX. On the Day of SX, eyes will receive in-office drops administered by study staff according to the following:
Eyes will then self-administer the following postoperative interventions: ketorolac drops QID x 1 month. Prednisolone acetate tapering QID x1 week, TID x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week; and moxifloxacin drops TID x 1 week. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide} | Drug | Eyes in the Study Arm will be treated with the following intraoperative interventions: Intracameral (OMIDRIA) phenylephrine 1.0%/ketorolac 0.3%, intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10mgs/mL). |
| Measure | Description | Time Frame |
|---|---|---|
| inflammation | The proportion of participants with inflammation on Day 8. (Participants will be considered to have no inflammation (Grade 0) if they have ≤ 2 anterior chamber cells and are asymptomatic.) {Anterior Inflammation Scale, 0-4 with 4 being the worst or most severe score} | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| SPEED Questionnaire | Mean change in SPEED Questionnaire from baseline to Day 8 and baseline to Day 30 | 30 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Singh, MD | Contact | 262-637-0500 | ipsingh@amazingeye.com | |
| Cathleen McCabe, MD | Contact | 941-493-3763 | mccabe131@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Paul Singh, MD | The Eye Centers of Racine & Kenosha | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Associates - Venice | Recruiting | Venice | Florida | 34292 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a 2-arm non-inferiority trial with the following arms:
Not provided
Not provided
The biostatistician analyzing the data will be masked to both treatment arm and surgery center.
When the Investigators or Sponsor look at the data, they will also be masked to treatment arm and surgery center.
|
|
| Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte} | Drug | On the Day of Surgery, eyes in the Control Arm will receive in-office drops administered by study staff according to the following schedule:
|
|
|
| The Eye Centers of Racine & Kenosha | Recruiting | Racine | Wisconsin | 53405 | United States |
|
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D010656 | Phenylephrine |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D000077266 | Moxifloxacin |
| C009935 | prednisolone acetate |
| D016568 | Drugs, Generic |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D004364 | Pharmaceutical Preparations |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
Not provided
Not provided