A Phase 2 interventional study of KPI-121 and Placebo in Dry Eye Syndromes and Keratoconjunctivitis Sicca, sponsored by Kala Pharmaceuticals, Inc.. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-06.
Sponsored by Kala Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 28 days, with 1-2 drops instilled in each eye four times daily (QID).
This is a Phase II, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.
Approximately 400 subjects will be screened and up to 150 subjects will be randomized at up to 12 centers located in the United States. Subjects will be randomized to 1 of 2 study arms in an approximate 1:1 ratio. The study arms are: 1) KPI-121 0.25% ophthalmic suspension administered 1-2 drops in each eye QID for up to 28 days or 2) vehicle administered as 1-2 drops in each eye QID for up to 28 days.
This study will include up to 6 clinic visits over 6 weeks. At Visit 1 Screening (14 ± 1 days prior to Day 1), subjects who meet screening inclusion/exclusion criteria will begin a 2-week run-in period during which they will be treated with 1-2 drops of single-masked vehicle in each eye QID for 14 ± 1 days.
At Visit 2, Randomization (Day 1), subjects who continue to meet inclusion/exclusion criteria will be eligible for randomization to 1 of the 2 arms of the study (i.e., KPI-121 0.25% ophthalmic suspension or vehicle). Following randomization, subjects will be instructed to return to the clinic to have a complete study evaluation at Study Visits 4 and 6 (Days 15 ± 1 day and 29 ± 1 day, respectively). Subjects will further be instructed to return to the clinic for diary collection and in-clinic symptom assessment only at Visits 3 and 5 (Days 8 ± 1 day and 22 ± 1 day, respectively). The last dose of investigational product and the final study visit will occur upon completion of 28 ± 1 days of exposure to investigational product. Subjects will be released from the study at the end of Visit 6 (Day 29 ± 1 day).
85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.
This study's enrollment of 150 is above the median of 82 across 75 interventional studies indexed under Keratoconjunctivitis Sicca.
Browse Keratoconjunctivitis Sicca studies →Kala Pharmaceuticals, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Compared within Keratoconjunctivitis Sicca, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dry Eye Syndromes. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease
Drug: KPI-121
Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease
Drug: Placebo
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.
Also known as: KPI-121 0.25% Ophthalmic Suspension, Loteprednol etabonate
Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
Also known as: Vehicle of KPI-121 0.25% Ophthalmic Suspension
Bulbar Conjunctival Hyperemia
Comparison of mean bulbar conjunctival hyperemia in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.
Time frame: Visit 6 (Day 29)
Ocular Discomfort
Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time frame: Visit 6 (Day 29)
Corneal Fluorescein Staining Scores
Comparison of mean corneal fluorescein staining scores in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe. The total score is obtained by summing each of the 5 sections of the cornea. The NEI score will be from 0-15.
Time frame: Visit 4 (Day 15) and Visit 6 (Day 29)
Bulbar Conjunctival Hyperemia Scores
Comparison of mean bulbar conjunctival hyperemia scores in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.
Time frame: Visit 4 (Day 15)
Ocular Discomfort
Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time frame: Visit 4 (Day 15)
| Milestone | KPI-121 0.25% Ophthalmic Suspension | Vehicle |
|---|---|---|
| Started | 73 | 77 |
| Completed | 72 | 76 |
| Not completed | 1 | 1 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Use of an excluded medication | 0 | 1 |
Comparison of mean bulbar conjunctival hyperemia in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.
| score on a scale | KPI-121 0.25% Ophthalmic Suspension | Vehicle |
|---|---|---|
| Bulbar Conjunctival Hyperemia | 1.22 ± 0.633 | 1.36 ± 0.626 |
Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
| score on a scale | KPI-121 0.25% Ophthalmic Suspension | Vehicle |
|---|---|---|
| Ocular Discomfort | 57.05 ± 23.892 | 60.47 ± 19.770 |
Comparison of mean corneal fluorescein staining scores in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe. The total score is obtained by summing each of the 5 sections of the cornea. The NEI score will be from 0-15.
| score on a scale | KPI-121 0.25% Ophthalmic Suspension | Vehicle |
|---|---|---|
| Visit 4 (Day 15) | 6.15 ± 2.582 | 7.00 ± 2.920 |
| Visit 6 (Day 29) | 5.64 ± 2.889 | 6.16 ± 3.445 |
Comparison of mean bulbar conjunctival hyperemia scores in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.
| score on a scale | KPI-121 0.25% Ophthalmic Suspension | Vehicle |
|---|---|---|
| Bulbar Conjunctival Hyperemia Scores | 1.36 ± 0.586 | 1.42 ± 0.676 |
Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
| score on a scale | KPI-121 0.25% Ophthalmic Suspension | Vehicle |
|---|---|---|
| Ocular Discomfort | 58.83 ± 20.745 | 63.63 ± 17.844 |
Collected over Adverse event data was collected from Visit 2 (Day 1) through Visit 6 (Day 29).. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | 0/72 (0%) | 1/72 (1.4%) | 7/72 (9.7%) |
| Vehicle | 0/78 (0%) | 0/78 (0%) | 8/78 (10.3%) |
| Event | KPI-121 0.25% Ophthalmic Suspension | Vehicle |
|---|---|---|
| CholelithiasisHepatobiliary disorders | 1/72 | 0/78 |
| Event | KPI-121 0.25% Ophthalmic Suspension | Vehicle |
|---|---|---|
| Instillation site painGeneral disorders | 7/72 | 8/78 |
| Age, Continuous(years) | KPI-121 0.25% Ophthalmic Suspension | Vehicle | Total |
|---|---|---|---|
| Mean | 56.3 ± 17.17 | 54.9 ± 12.29 | 55.6 ± 14.83 |
| Sex: Female, Male(Participants) | KPI-121 0.25% Ophthalmic Suspension | Vehicle | Total |
|---|---|---|---|
| Female | 53 | 61 | 114 |
| Male | 20 | 16 | 36 |
| Ethnicity (NIH/OMB)(Participants) | KPI-121 0.25% Ophthalmic Suspension | Vehicle | Total |
|---|---|---|---|
| Hispanic or Latino | 15 | 16 | 31 |
| Not Hispanic or Latino | 58 | 61 | 119 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | KPI-121 0.25% Ophthalmic Suspension | Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 4 | 7 |
| Native Hawaiian or Other Pacific Islander | 2 | 1 | 3 |
| Black or African American | 10 | 8 | 18 |
| White | 54 | 63 | 117 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 4 | 0 | 4 |
| Region of Enrollment(participants) | KPI-121 0.25% Ophthalmic Suspension | Vehicle | Total |
|---|---|---|---|
| United States | 73 | 77 | 150 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Jun 2014, a primary completion of Jan 2015 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2021, 6 years after primary completion. A results delay was requested in Jul 2016.
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Studies of the drug tested here: Loteprednol Etabonate
Kala Pharmaceuticals, Inc.