Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
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| ClinicalTrials.gov Identifier: NCT02793817 |
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Recruitment Status :
Completed
First Posted : June 8, 2016
Results First Posted : April 17, 2019
Last Update Posted : December 16, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Post Surgical Ocular Inflammation and Pain | Drug: KPI-121 1% Ophthalmic Suspension dosed BID Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 520 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Double-Masked, Randomized, Controlled Study to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain |
| Actual Study Start Date : | June 2016 |
| Actual Primary Completion Date : | March 2017 |
| Actual Study Completion Date : | March 2017 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: KPI-121 1.0% Ophthalmic Suspension
dosed BID
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Drug: KPI-121 1% Ophthalmic Suspension dosed BID
Other Name: Loteprednol etabonate |
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Placebo Comparator: Vehicle of KPI-121 Ophthalmic Suspension
dosed BID
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Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID
Other Name: Placebo |
- Complete Resolution of Anterior Chamber (AC) Cells at Day 8 [ Time Frame: Visit 5 (Day 8) maintained through Visit 6 (Day 15) ]
Number and percentage of subjects with complete resolution of AC cells in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.
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 - 5 cells
- = 6 - 15 cells
- = 16 - 30 cells
- = greater than 30 cells
- Complete Resolution of Ocular Pain at Day 8 [ Time Frame: Visit 5 (Day 8) maintained through Visit 6 (Day 15) ]
Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.
Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes.
The following scoring scale was used for ocular pain:
0 = None
- = Minimal
- = Mild
- = Moderate
- = Moderately Severe
- = Severe
- Complete Resolution of Ocular Pain at Day 4 [ Time Frame: Visit 4 (Day 4) maintained through Visit 6 (Day 15) ]
Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.
Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes.
The following scoring scale was used for ocular pain:
0 = None
- = Minimal
- = Mild
- = Moderate
- = Moderately Severe
- = Severe
- Complete Resolution of Anterior Chamber (AC) Flare at Day 4 [ Time Frame: Visit 4 (Day 4) maintained through Visit 6 (Day 15) ]
Number and percentage of subjects with complete resolution of AC flare in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.
Investigators were asked to grade AC flare based on the following scale wherein higher scores indicate a higher degree of flare present and a decrease across time indicates the condition is getting better.
Anterior Chamber Flare 0 = None
- = Mild (trace to clearly noticeable, visible)
- = Moderate (without plastic aqueous humor)
- = Marked (with plastic aqueous humor)
- = Severe (with fibrin deposits and/or clots)
- Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4 [ Time Frame: Visit 1 (Baseline) and Visit 4 (Day 4) ]
The difference in mean changes from BL in AC cell count grade at Day 4 for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.
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 - 5 cells
- = 6 - 15 cells
- = 16 - 30 cells
- = greater than 30 cells
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
- Known hypersensitivity/contraindication to study product(s) or components.
- History of glaucoma, intraocular pressure (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 18 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793817
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Documents provided by Kala Pharmaceuticals, Inc.:
| Responsible Party: | Kala Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT02793817 |
| Other Study ID Numbers: |
KPI-121-C-005 |
| First Posted: | June 8, 2016 Key Record Dates |
| Results First Posted: | April 17, 2019 |
| Last Update Posted: | December 16, 2020 |
| Last Verified: | October 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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postsurgical postoperative ocular cataract |
inflammation pain corticosteroid |
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Inflammation Pathologic Processes Loteprednol Etabonate Anti-Allergic Agents |