Post Surgical Ocular Inflammation and PainPhase 3NCT02793817
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
A Phase 3 study testing KPI-121 1% Ophthalmic Suspension dosed BID in people with Post Surgical Ocular Inflammation and Pain, run by Kala Pharmaceuticals, Inc. at 35 sites in United States.
Trial summary
The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0% ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Surgical Ocular Inflammation and Pain
- What is being tested?
- KPI-121 1% Ophthalmic Suspension dosed BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 35 sitesUnited States
- Study dates
- Jun 2016to Mar 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Sall Research Medical Center
Artesia, California, 90701
Texan Eye, PA / Keystone Research, Ltd
Austin, Texas, 78731
Minnesota Eye Consultants, PA
Bloomington, Minnesota, 55431
Arizona Eye Center
Chandler, Arizona, 85225
Apex Eye
Cincinnati, Ohio, 45247
Duke University Eye Center
Durham, North Carolina, 27703
The Cataract & Glaucoma Center
El Paso, Texas, 79902
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, 80525
Eye Associates of Fort Myers
Fort Myers, Florida, 33901
Orange County Ophthalmology
Garden Grove, California, 92843
Lugene Eye Institute
Glendale, California, 91204
Inland Eye Specialists
Hemet, California, 92545
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, 60169
Houston Eye Associates
Houston, Texas, 77024
United Medical Research Institute
Inglewood, California, 90301
Levenson Eye Associates
Jacksonville, Florida, 32204
Eye Care Specialists
Kingston, Pennsylvania, 18704
Carolina Cataract & Laser Center
Ladson, South Carolina, 29456
Jacksoneye, S. C.
Lake Villa, Illinois, 60046
Shettle Eye Research, Inc
Largo, Florida, 33773
Abrams Eye Institute
Las Vegas, Nevada, 89148
The Eye Care Institute
Louisville, Kentucky, 40206
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, 29464
LoBue Laser and Eye Medical Center
Murrieta, California, 92562
Pendleton Eye Center
Oceanside, California, 92056
North Bay Eye Associates, Inc.
Petaluma, California, 94954
Cornea and Cataract Consultants of CA
Phoenix, Arizona, 85032
Arch Health Partners
Poway, California, 92064
Martel Eye Medical Group
Rancho Cordova, California, 95670
Shasta Eye Medical Group, Inc
Redding, California, 96002
Roseburg Research Associates, LLC
Roseburg, Oregon, 97471
Great Lakes Eye Care
Saint Joseph, Michigan, 49085
Kozlovsky Delay & Winter Eye Consultants, LLC Corona Research
San Antonio, Texas, 78213
International Research Center
Tampa, Florida, 33603
Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
Washington, Missouri, 63090
About this study
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
The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0% ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.
Read the detailed description
This is a Phase III, multicenter, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 1.0% ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.
- Being tested
- KPI-121 1% Ophthalmic Suspension dosed BID, Vehicle of KPI-121 Ophthalmic Suspension dosed BID
- Keywords
- postsurgical, postoperative, ocular, cataract, inflammation, pain, corticosteroid
- Medical subject headings
- Pain, Cataract, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPI-121 1% Ophthalmic Suspension dosed BIDDrug
Also called Loteprednol etabonate
Vehicle of KPI-121 Ophthalmic Suspension dosed BIDDrug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| KPI-121 1.0% Ophthalmic Suspension | Active comparator | dosed BID Receives: Drug: KPI-121 1% Ophthalmic Suspension dosed BID |
| Vehicle of KPI-121 Ophthalmic Suspension | Placebo comparator | dosed BID Receives: Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Resolution of Anterior Chamber (AC) Cells at Day 8
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
Measured: Visit 5 (Day 8) maintained through Visit 6 (Day 15)
Complete Resolution of Ocular Pain at Day 8
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
Measured: Visit 5 (Day 8) maintained through Visit 6 (Day 15)
Secondary outcomes (3)
Complete Resolution of Ocular Pain at Day 4
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
Measured: Visit 4 (Day 4) maintained through Visit 6 (Day 15)
Complete Resolution of Anterior Chamber (AC) Flare at Day 4
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)
Measured: Visit 4 (Day 4) maintained through Visit 6 (Day 15)
Change From Baseline (BL) Anterior Chamber (AC) Cells at 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
Measured: Visit 1 (Baseline) and Visit 4 (Day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Surgical Ocular Inflammation and PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kala Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793817
- Sponsor's protocol ID
- KPI-121-C-005
- Status last verified
- Oct 2018
- First submitted
- 3 Jun 2016
- Last updated
- 16 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02793817
- Acronym / sponsor ID
- KPI-121-C-005
- Keywords
- postsurgical, postoperative, ocular, cataract, inflammation, pain, corticosteroid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Kala Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Posted 17 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0% ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.
Detailed description
This is a Phase III, multicenter, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 1.0% ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KPI-121 1.0% Ophthalmic Suspension | Active comparator | Drug: KPI-121 1% Ophthalmic Suspension dosed BIDdosed BID |
| Vehicle of KPI-121 Ophthalmic Suspension | Placebo comparator | Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BIDdosed BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KPI-121 1% Ophthalmic Suspension dosed BIDAlso: Loteprednol etabonate | Drug | KPI-121 1.0% Ophthalmic Suspension |
| Vehicle of KPI-121 Ophthalmic Suspension dosed BIDAlso: Placebo | Drug | Vehicle of KPI-121 Ophthalmic Suspension |
Primary outcome
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. = 1 - 5 cells 2. = 6 - 15 cells 3. = 16 - 30 cells 4. = 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 1. = Minimal 2. = Mild 3. = Moderate 4. = Moderately Severe 5. = Severe
3 secondary outcomes
Complete Resolution of Ocular Pain at Day 4
Time frame: Visit 4 (Day 4) maintained through Visit 6 (Day 15)
Complete Resolution of Anterior Chamber (AC) Flare at Day 4
Time frame: Visit 4 (Day 4) maintained through Visit 6 (Day 15)
Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4
Time frame: Visit 1 (Baseline) and Visit 4 (Day 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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RecruitingPhase 4
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KPI-121 1% Ophthalmic Suspension dosed BID in people with Post Surgical Ocular Inflammation and Pain, run by Kala Pharmaceuticals, Inc. at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Resolution of Anterior Chamber (AC) Cells at Day 8 (time frame: Visit 5 (Day 8) maintained through Visit 6 (Day 15)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.