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CompletedNCT03616899STRIDE 3Updated Apr 2, 2021Results posted

Safety and Efficacy of KPI-121 in Subjects With DED

A Phase 3 interventional study of KPI-121 Ophthalmic Suspension and Vehicle in Kerato Conjunctivitis Sicca, sponsored by Kala Pharmaceuticals, Inc.. Completed at 81 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-02.

Sponsored by Kala Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
901
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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 14 days, with 1-2 drops instilled in each eye four times daily (QID).

Read the detailed description

This is a Phase 3, 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.

02

Conditions studied

  • Kerato Conjunctivitis Sicca

Browse trials for

03

In context

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

This study's enrollment of 901 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Kala Pharmaceuticals, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Have a documented clinical diagnosis of dry eye disease in both eyes

Exclusion criteria

Exclusion Criteria:

  • Known or to the 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; or have been exposed to an investigational drug within 30 days prior to screening.
  • In the opinion of the Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
Terms in these criteria, in plain language(3)

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.

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.

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
901 participants (actual)

Study arms

  • Active comparator
    KPI-121 0.25% Ophthalmic Suspension

    Drug: KPI-121 Ophthalmic Suspension

  • Placebo comparator
    Vehicle of KPI-121 0.25% Ophthalmic Suspension

    Drug: Vehicle

Interventions

06

What researchers measure

Primary outcomes

  1. Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)

    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: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

  2. Change From Baseline/Visit 2 (Day 1) Ocular Discomfort Severity at Visit 4 (Day 15) in the Subgroup of Participants With More Severe 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, in a sub-group of participants with more severe ocular discomfort at baseline.

    Time frame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

Secondary outcomes

  1. Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)

    Comparison of mean bulbar conjunctival hyperemia 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: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

  2. Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor

    Comparison of mean bulbar conjunctival hyperemia 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: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

  3. Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 3 (Day 8)

    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: Baseline/Visit 2 (Day 1) to Visit 3 (Day 8)

  4. Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)

    Comparison of mean corneal fluorescein staining 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.

    Time frame: Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)

  5. Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean

    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: Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)

07

Results

Posted Apr 2, 2021

Participant flow

Participant flow — Overall Study
MilestoneKPI-121 0.25% Ophthalmic SuspensionVehicle of KPI-121 0.25% Ophthalmic Suspension
Started447454
Completed437453
Not completed101

Outcome measures

PrimaryChange From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)

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:
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Reported as:
Mean · score on a scale
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)
score on a scaleKPI-121 0.25% Ophthalmic SuspensionVehicle of KPI-121 0.25% Ophthalmic Suspension
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)-13.58 ± 19.379-8.91 ± 17.579
PrimaryChange From Baseline/Visit 2 (Day 1) Ocular Discomfort Severity at Visit 4 (Day 15) in the Subgroup of Participants With More Severe 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, in a sub-group of participants with more severe ocular discomfort at baseline.

Time frame:
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Reported as:
Mean · score on a scale
Change From Baseline/Visit 2 (Day 1) Ocular Discomfort Severity at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort
score on a scaleKPI-121 0.25% Ophthalmic SuspensionVehicle of KPI-121 0.25% Ophthalmic Suspension
Change From Baseline/Visit 2 (Day 1) Ocular Discomfort Severity at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort-15.59 ± 20.373-10.15 ± 18.739
SecondaryChange From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)

Comparison of mean bulbar conjunctival hyperemia 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:
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Reported as:
Mean · score on a scale
Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
score on a scaleKPI-121 0.25% Ophthalmic SuspensionVehicle of KPI-121 0.25% Ophthalmic Suspension
Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)-0.35 ± 0.575-0.18 ± 0.546
SecondaryChange in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor

Comparison of mean bulbar conjunctival hyperemia 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:
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Reported as:
Mean · score on a scale
Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor
score on a scaleKPI-121 0.25% Ophthalmic SuspensionVehicle of KPI-121 0.25% Ophthalmic Suspension
Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor-0.61 ± 0.646-0.48 ± 0.657
SecondaryChange From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 3 (Day 8)

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:
Baseline/Visit 2 (Day 1) to Visit 3 (Day 8)
Reported as:
Median · score on a scale
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 3 (Day 8)
score on a scaleKPI-121 0.25% Ophthalmic SuspensionVehicle of KPI-121 0.25% Ophthalmic Suspension
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 3 (Day 8)-8.05 ± 15.009-5.83 ± 15.176
SecondaryChange From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)

Comparison of mean corneal fluorescein staining 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.

Time frame:
Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)
Reported as:
Mean · score on a scale
Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)
score on a scaleKPI-121 0.25% Ophthalmic SuspensionVehicle of KPI-121 0.25% Ophthalmic Suspension
Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)-0.53 ± 0.800-0.43 ± 0.739
SecondaryChange From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean

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:
Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)
Reported as:
Mean · score on a scale
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean
score on a scaleKPI-121 0.25% Ophthalmic SuspensionVehicle of KPI-121 0.25% Ophthalmic Suspension
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean-11.76 ± 18.035-7.91 ± 16.298

Adverse events

Collected over Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
KPI-121 0.25% Ophthalmic Suspension0/449 (0%)3/449 (0.7%)39/449 (8.7%)
Vehicle of KPI-121 0.25% Ophthalmic Suspension0/452 (0%)1/452 (0.2%)26/452 (5.8%)
Most frequent serious events
Most frequent serious events
EventKPI-121 0.25% Ophthalmic SuspensionVehicle of KPI-121 0.25% Ophthalmic Suspension
Atrioventricular BlockCardiac disorders1/4490/452
Joint dislocationInjury, poisoning and procedural complications1/4490/452
Delusional disorder, unspecified typePsychiatric disorders1/4490/452
Schizoaffective disorderPsychiatric disorders1/4490/452
Eyelid injuryInjury, poisoning and procedural complications0/4491/452
Most frequent other events
Showing 10 of 49
Most frequent other events
EventKPI-121 0.25% Ophthalmic SuspensionVehicle of KPI-121 0.25% Ophthalmic Suspension
Instillation site painGeneral disorders13/4497/452
Dry eyeEye disorders1/4493/452
Eye pruritusEye disorders1/4493/452
Eye irritationEye disorders2/4491/452
Vision blurredEye disorders2/4490/452
Blood pressure increasedInvestigations2/4490/452
HeadacheNervous system disorders2/4491/452
Neck painMusculoskeletal and connective tissue disorders2/4490/452
Instillation site dischargeGeneral disorders1/4490/452
Instillation site pruritusGeneral disorders1/4490/452

Baseline characteristics

Age, Continuous
Age, Continuous(years)KPI-121 0.25% Ophthalmic SuspensionVehicle of KPI-121 0.25% Ophthalmic SuspensionTotal
Mean57.6 ± 15.2657.3 ± 15.5357.4 ± 15.39
Sex: Female, Male
Sex: Female, Male(Participants)KPI-121 0.25% Ophthalmic SuspensionVehicle of KPI-121 0.25% Ophthalmic SuspensionTotal
Female339330669
Male108124232
Race (NIH/OMB)
Race (NIH/OMB)(Participants)KPI-121 0.25% Ophthalmic SuspensionVehicle of KPI-121 0.25% Ophthalmic SuspensionTotal
American Indian or Alaska Native011
Asian263763
Native Hawaiian or Other Pacific Islander000
Black or African American7173144
White348341689
More than one race011
Unknown or Not Reported213
Region of Enrollment
Region of Enrollment(participants)KPI-121 0.25% Ophthalmic SuspensionVehicle of KPI-121 0.25% Ophthalmic SuspensionTotal
United States447454901
08

Study locations

81 sites
  • Investigator #133
    Birmingham, Alabama 35294, United States
  • Investigator #278
    Dothan, Alabama 36301, United States
  • Investigator #146
    Chandler, Arizona 85224, United States
  • Investigator #148
    Phoenix, Arizona 85032, United States
  • Investigator #280
    Prescott, Arizona 86301, United States
  • Investigator #276
    Sun City, Arizona 85351, United States
  • Investigator #185
    Azusa, California 91702, United States
  • Investigator #143
    Garden Grove, California 92843, United States
  • Investigator #147
    Glendale, California 91204, United States
  • Investigator #272
    Hemet, California 92545, United States
  • Investigator #155
    Inglewood, California 90301, United States
  • Investigator #273
    Long Beach, California 90805, United States
  • Investigator #130
    Mission Hills, California 91345, United States
  • Investigator #247
    Murrieta, California 92562, United States
  • Investigator #215
    Newport Beach, California 92663, United States
  • Site #111
    Rancho Cordova, California 95670, United States
  • Investigator #271
    Santa Ana, California 92705, United States
  • Investigator #107
    Torrance, California 90505, United States
  • Investigator #213
    Westminster, California 92683, United States
  • Investigator #218
    Littleton, Colorado 80120, United States
  • Investigator #184
    Brooksville, Florida 34613, United States
  • Investigator #262
    Delray Beach, Florida 33484, United States
  • Investigator #279
    Fort Myers, Florida 33901, United States
  • Investigator #265
    Jacksonville, Florida 32256, United States
  • Investigator #157
    Largo, Florida 33773, United States
  • Investigator #189
    Tampa, Florida 33603, United States
  • Investigator #136
    Morrow, Georgia 30260, United States
  • Investigator #268
    Roswell, Georgia 30076, United States
  • Investigator #266
    Chicago, Illinois 60616, United States
  • Investigator #187
    Hoffman Estates, Illinois 60169, United States
  • Investigator #151
    Lake Villa, Illinois 60046, United States
  • Investigator #128
    Indianapolis, Indiana 46260, United States
  • Investigator #250
    Indianapolis, Indiana 46290, United States
  • Investigator #125
    New Albany, Indiana 47150, United States
  • Investigator #274
    Lexington, Kentucky 40517, United States
  • Investigator #195
    Louisville, Kentucky 40206, United States
  • Investigator #168
    Louisville, Kentucky 40220, United States
  • Investigator #219
    Winchester, Massachusetts 01890, United States
  • Investigator #267
    Kansas City, Missouri 64133, United States
  • Investigator #123
    Saint Louis, Missouri 63128, United States
  • Investigator #106
    Saint Louis, Missouri 63131, United States
  • Investigator #126
    Saint Louis, Missouri 63131, United States
  • Investigator #131
    Washington, Missouri 63090, United States
  • Investigator #281
    Henderson, Nevada 89052, United States
  • Investigator #275
    Las Vegas, Nevada 89123, United States
  • Investigator #263
    Las Vegas, Nevada 89145, United States
  • Investigator #138
    Las Vegas, Nevada 89148, United States
  • Investigator #105
    New York, New York 10013, United States
  • Investigator #108
    Rochester, New York 14618, United States
  • Investigator #132
    Wantagh, New York 11793, United States
  • Investigator #264
    Asheville, North Carolina 28803, United States
  • Investigator #217
    Durham, North Carolina 27704, United States
  • Investigator #149
    Durham, North Carolina 27710, United States
  • Investigator #102
    High Point, North Carolina 27262, United States
  • Investigator #163
    Raleigh, North Carolina 27603, United States
  • Investigator #282
    Southern Pines, North Carolina 28387, United States
  • Investigator #269
    Cincinnati, Ohio 45242, United States
  • Investigator #142
    Cincinnati, Ohio 45247, United States
  • Investigator #137
    Cleveland, Ohio 44115, United States
  • Investigator #171
    Mason, Ohio 45040, United States
  • Investigator #224
    Cranberry Township, Pennsylvania 16066, United States
  • Investigator #156
    Kingston, Pennsylvania 18704, United States
  • Investigator #200
    Lancaster, Pennsylvania 17601, United States
  • Investigator #277
    West Mifflin, Pennsylvania 15122, United States
  • Investigator #240
    Rapid City, South Dakota 57701, United States
  • Investigator #127
    Memphis, Tennessee 38119, United States
  • Investigator #270
    Austin, Texas 78681, United States
  • Investigator #188
    Austin, Texas 78731, United States
  • Investigator #174
    Cedar Park, Texas 78613, United States
  • Investigator #140
    El Paso, Texas 79902, United States
  • Investigator #124
    Houston, Texas 77055, United States
  • Investigator #259
    Houston, Texas 77204, United States
  • Investigator #175
    Lakeway, Texas 78734, United States
  • Investigator #182
    League City, Texas 77573, United States
  • Investigator #191
    League City, Texas 77573, United States
  • Site #177
    San Antonio, Texas 78209, United States
  • Investigator #258
    San Antonio, Texas 78229, United States
  • Investigator #186
    San Antonio, Texas 78230, United States
  • Investigator #176
    San Antonio, Texas 78240, United States
  • Investigator #222
    Layton, Utah 84041, United States
  • Investigator #119
    Norfolk, Virginia 23502, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Feb 2020, 18 months.

Results were first posted in Apr 2021, 1 year 1 month after primary completion.

Of 81 industry-sponsored phase 3 interventional studies under Dry Eye Syndromes, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 15. This study's 18 months is above that.

Counting every sponsor, half of 96 studies reached it within 10 months; a quarter within 7 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2018
First posted
Aug 6, 2018
StartActual
Jul 10, 2018
Primary completionActual
Feb 5, 2020
CompletionActual
Feb 5, 2020
Results first posted
Apr 2, 2021
Last update
Apr 2, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03616899
Lead sponsor
Kala Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Aug 6, 2018
Start date
Jul 10, 2018
Primary completion
Feb 5, 2020
Completion
Feb 5, 2020
Results posted
Apr 2, 2021
Last update
Apr 2, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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