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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KPI-121 0.25% QID | Active Comparator | 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 | Active Comparator | KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant. |
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| Vehicle of KPI-121 0.25% | Placebo Comparator | 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% | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KPI-121 0.25% | Drug | KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of Anterior Chamber Cells | 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
| Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15) |
| Resolution of Ocular Pain | Subjects with complete resolution of pain (grade = 0) without rescue medication at Day 8/Visit 5 and Day 15/Visit 6. | Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Cell Grade at Visit 5. | 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
|
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FURTHER STUDY DETAILS PROVIDED BY KALA PHARMACEUTICALS, INC.
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sall Research Medical Center | Artesia | California | 90701 | United States | ||
| North Valley Eye Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | KPI-121 0.25% QID | 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 0.25%: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2014 |
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| KPI-121 1.0% | Drug | KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. |
|
|
| Vehicle of KPI-121 0.25% | Drug | Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate. |
|
|
| Vehicle of KPI-121 1.0% | Drug | Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate. |
|
|
| Visit 5 (postoperative day 8) |
| Anterior Chamber Cell Grade at Visit 6. | 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
| Visit 6 (postoperative day 15) |
| Ocular Pain Grades at 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
| Visit 5 (postoperative day 8) |
| Ocular Pain Grades at 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
| Visit 6 (postoperative day 15) |
| Mission Hills |
| California |
| 91345 |
| United States |
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | United States |
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | United States |
| Clayton Eye Center | Morrow | Georgia | 30260 | United States |
| Price Vision Group | Indianapolis | Indiana | 46260 | United States |
| John-Kenyon American Eye Institute | New Albany | Indiana | 47150 | United States |
| Taustine Eye Center | Louisville | Kentucky | 40217 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| Tekwani Vision Center | St Louis | Missouri | 63128 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Ophthalmology Consultants | St Louis | Missouri | 63131 | United States |
| Las Vegas Physicians Research Group | Henderson | Nevada | 89052 | United States |
| Raymond Fong, MDPC | New York | New York | 10013 | United States |
| Rochester Ophthalmological Group, PC | Rochester | New York | 14618 | United States |
| Cornerstone Eye Care | High Point | North Carolina | 27262 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| The Eye Center of Columbus | Columbus | Ohio | 43215 | United States |
| Westside Research, LLC | Spartanburg | South Carolina | 29306 | United States |
| The Eye Clinic of Texas, Affiliate of Houston Eye Associates | League City | Texas | 77573 | United States |
| R&R Eye Research, LLC | San Antonio | Texas | 78229 | United States |
| Kozlovsky Delay & Winter Eye Consultants, LLC | San Antonio | Texas | 78230 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| FG001 | KPI-121 1.0% BID | 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 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. |
| FG002 | Vehicle of KPI-121 | Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant. Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | KPI-121 0.25% QID | 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 0.25%: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. |
| BG001 | KPI-121 1.0% BID | 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 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. |
| BG002 | Vehicle of KPI-121 | Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant. Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Resolution of Anterior Chamber Cells | 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
| Intent to treat- all subjects randomized | Posted | Count of Participants | Participants | Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15) |
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| Primary | Resolution of Ocular Pain | Subjects with complete resolution of pain (grade = 0) without rescue medication at Day 8/Visit 5 and Day 15/Visit 6. | Intent to Treat- all subjects randomized. | Posted | Count of Participants | Participants | Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anterior Chamber Cell Grade at Visit 5. | 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
| Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Visit 5 (postoperative day 8) |
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| Secondary | Anterior Chamber Cell Grade at Visit 6. | 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
| Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Visit 6 (postoperative day 15) |
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| Secondary | Ocular Pain Grades at 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
| Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Visit 5 (postoperative day 8) |
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| Secondary | Ocular Pain Grades at 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
| Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Visit 6 (postoperative day 15) |
|
Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KPI-121 0.25% QID | 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 0.25%: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. | 0 | 129 | 2 | 129 | 13 | 129 |
| EG001 | KPI-121 1.0% BID | 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 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. | 0 | 125 | 1 | 125 | 6 | 125 |
| EG002 | Vehicle of KPI-121 | Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant. Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate. | 0 | 126 | 2 | 126 | 20 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
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| Cystoid macular oedema | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| eye pain | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| photophobia | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| punctate keratitis | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| eye inflammation | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| ocular discomfort | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| ocular hyperaemia | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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| eye irritation | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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| corneal oedema | Eye disorders | MedDRA (16.1) | Systematic Assessment |
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The agreement between the Principal Investigator and the Sponsor restricts the PI's rights to discuss or publish trial results until after the first to occur of the following:
(a) publication of such multi-center clinical trial results; (b) notification by sponsor that such a multi-center clinical trial submission is no longer planned; or ( c) the eighteen ( 18) month anniversary of the completion, abandonment or termination of such multi-center clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Development | Kala Pharmaceuticals, Inc | Results001@kalarx.com |
| Nov 25, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007249 | Inflammation |
| D002386 | Cataract |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007905 | Lens Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided. All statistical tests employed a level of significance of alpha = 0.05. |
| Chi-squared |
| <.0001 |
| Difference in % of responders |
| 22.1 |
| 2-Sided |
| 95 |
| 11.7 |
| 32.6 |
Estimated Value is the between-group difference for % of responders and is expressed as a percentage. |
| Superiority |
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| OG002 | Vehicle of KPI-121 | Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant. Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate. |
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| OG002 | Vehicle of KPI-121 | Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant. Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate. |
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| OG002 | Vehicle of KPI-121 | Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant. Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate. |
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| OG002 | Vehicle of KPI-121 | Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant. Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate. |
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