Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation
- Conditions
- Ocular Infections, Irritations and Inflammations
- Interventions
- Registration Number
- NCT02163824
- Lead Sponsor
- Kala Pharmaceuticals, Inc.
- Brief Summary
The primary purpose of this study is to determine the efficacy and safety of KPI-121 ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery. The efficacy and safety of two different concentrations and two different dosing regimens of KPI-121 are also being assessed.
- Detailed Description
This is a Phase III, multicenter, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of two doses and two dosing regimens of KPI-121 ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.
Approximately 500 subjects will be screened and up to 402 subjects with one study eye each will be randomized in this study at approximately 25 centers located in the United States. Subjects who experience postoperative inflammation on the first day following routine, uncomplicated, cataract surgery and who meet all other eligibility criteria will be randomized to one of four study groups (0.25% four times daily or 1.0% two times daily) or Placebo A four times daily or Placebo B two times daily. Drug product or placebo will be initiated on the day following surgery and instilled as one to two drops in the study eye according to the assigned dosing regimen for 14 days.
This study will include up to 7 clinic visits (including the surgery day) over 18 to 33 days total study duration. Visit 1 (Screening) will occur between 14 to 1 day(s) prior to surgery, and subjects who meet preoperative screening inclusion/exclusion criteria will be entered into the study. At Visit 2 (Surgery/Day 0) subjects will undergo routine cataract surgery according to the Investigator's normal procedures. Visit 3 (Randomization/Day 1) will occur on the day following surgery.
Following randomization, subjects will be instructed to return to the clinic to be evaluated at Visit 4 (Day 3 +2 day), Visit 5 (Day 8 ±1 day), and Visit 6 (Day 15 ±1 day). The last dose of study product will be administered upon completion of 14 days of evaluation. Following the End of Study Product Use Visit (Visit 6; Day 15 ±1 day), subjects will be asked to return to the clinic on Day 17-19 for Visit 7 (Follow-Up) and will be released from the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 380
- Candidates for routine, uncomplicated cataract surgery
- In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of at least 20/200 in study eye.
- Known hypersensitivity/contraindication to study product(s) or components.
- History of glaucoma, IOP >21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
- Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening or 19 days following surgery.
- In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle of KPI-121 0.25% Vehicle of KPI-121 0.25% Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant. Vehicle of KPI-121 1.0% Vehicle of KPI-121 1.0% Vehicle of KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant. KPI-121 0.25% QID KPI-121 0.25% KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant. KPI-121 1.0% BID KPI-121 1.0% KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
- Primary Outcome Measures
Name Time Method Resolution of Anterior Chamber Cells Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15) Subjects with complete resolution of anterior chamber cells (cell score = 0) without rescue medication at Day 8/Visit 5 and Day 15/Visit 6.
0= No cells seen
1. 1 to 5 cells
2. 6 to 15 cells
3. 16 to 30 cells
4. greater than 30 cellsResolution of Ocular Pain Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15) Subjects with complete resolution of pain (grade = 0) without rescue medication at Day 8/Visit 5 and Day 15/Visit 6.
- Secondary Outcome Measures
Name Time Method Anterior Chamber Cell Grade at Visit 5. Visit 5 (postoperative day 8) Mean Grade of Anterior Chamber Cells (Scale 0-4) at Visit 5/Day 8. The difference in mean grade of AC cell count grade at Day 8 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better.
Anterior Chamber Cells 0 = No cells seen
1. 1 - 5 cells
2. 6 - 15 cells
3. 16 - 30 cells 4 = greater than 30 cellsOcular Pain Grades at Day 8. Visit 5 (postoperative day 8) Mean Grade of Ocular Pain (Scale 0-5) at Visit 5/Day 8. The difference in mean grade of ocular pain grade at Day 8 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain. Higher scores were worse outcomes.
The following scoring scale was used for ocular pain:
0 = None
1. Minimal
2. Mild
3. Moderate
4. Moderately Severe
5. SevereOcular Pain Grades at Day 15. Visit 6 (postoperative day 15) Mean Grade of Ocular Pain (Scale 0-5) at Visit 6/Day 15. The difference in mean grade of ocular pain grade at Day 15 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain.
Higher scores were worse outcomes.
The following scoring scale was used for ocular pain:
0 = None
1. Minimal
2. Mild
3. Moderate
4. Moderately Severe
5. SevereAnterior Chamber Cell Grade at Visit 6. Visit 6 (postoperative day 15) Mean Grade of Anterior Chamber Cells (Scale 0-4) at Visit 6/Day 15. The difference in mean grade of AC cell count grade at Day 15 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better.
Anterior Chamber Cells 0 = No cells seen
1. 1 - 5 cells
2. 6 - 15 cells
3. 16 - 30 cells 4 = greater than 30 cells
Trial Locations
- Locations (23)
Westside Research, LLC
🇺🇸Spartanburg, South Carolina, United States
Price Vision Group
🇺🇸Indianapolis, Indiana, United States
Sall Research Medical Center
🇺🇸Artesia, California, United States
North Valley Eye Medical Group
🇺🇸Mission Hills, California, United States
Martel Eye Medical Group
🇺🇸Rancho Cordova, California, United States
Clayton Eye Center
🇺🇸Morrow, Georgia, United States
Wolstan & Goldberg Eye Associates
🇺🇸Torrance, California, United States
Taustine Eye Center
🇺🇸Louisville, Kentucky, United States
Tekwani Vision Center
🇺🇸Saint Louis, Missouri, United States
Tauber Eye Center
🇺🇸Kansas City, Missouri, United States
Ophthalmology Associates
🇺🇸Saint Louis, Missouri, United States
Ophthalmology Consultants
🇺🇸Saint Louis, Missouri, United States
Raymond Fong, MDPC
🇺🇸New York, New York, United States
Las Vegas Physicians Research Group
🇺🇸Henderson, Nevada, United States
Rochester Ophthalmological Group, PC
🇺🇸Rochester, New York, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Cornerstone Eye Care
🇺🇸High Point, North Carolina, United States
The Eye Clinic of Texas, Affiliate of Houston Eye Associates
🇺🇸League City, Texas, United States
The Eye Center of Columbus
🇺🇸Columbus, Ohio, United States
R&R Eye Research, LLC
🇺🇸San Antonio, Texas, United States
Kozlovsky Delay & Winter Eye Consultants, LLC
🇺🇸San Antonio, Texas, United States
Virginia Eye Consultants
🇺🇸Norfolk, Virginia, United States
John-Kenyon American Eye Institute
🇺🇸New Albany, Indiana, United States