Kerato Conjunctivitis SiccaPhase 3STRIDE 3NCT03616899

Safety and Efficacy of KPI-121 in Subjects With DED

A Phase 3 study testing KPI-121 Ophthalmic Suspension in people with Kerato Conjunctivitis Sicca, run by Kala Pharmaceuticals, Inc. at 81 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kerato Conjunctivitis Sicca
What is being tested?: KPI-121 Ophthalmic Suspension
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 901 participants
Where: 81 sitesUnited States
Study dates: 10 Jul 2018to 5 Feb 2020
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

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

Who cannot join

Known hypersensitivity or contraindication to the investigational 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.

Trial locations and contacts

81 sites in 1 country.

City, postcode or hospital

81 sites in 1 country

United States81 sites

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

Other trials in United States

About this study

Official title: A Phase 3, Double-masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle In Subjects With Dry Eye Disease (STRIDE 3)

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.

Conditions: Kerato Conjunctivitis Sicca
Being tested: KPI-121 Ophthalmic Suspension, Vehicle
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KPI-121 Ophthalmic SuspensionDrug
KPI-121 Ophthalmic Suspension
VehicleDrug
Vehicle for KPI-121 0.25% ophthalmic suspension

Study groups in NCT03616899
Study group	Role	What they receive
KPI-121 0.25% Ophthalmic Suspension	Active comparator	Not described Receives: Drug: KPI-121 Ophthalmic Suspension
Vehicle of KPI-121 0.25% Ophthalmic Suspension	Placebo comparator	Not described Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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.
Measured: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
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.
Measured: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
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.
Measured: Baseline/Visit 2 (Day 1) to Visit 3 (Day 8)
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.
Measured: Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)
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.
Measured: Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 20185 Feb 2020

First posted6 Aug 2018
Study start10 Jul 2018
Primary completion5 Feb 2020
Study completion5 Feb 2020

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 Kerato Conjunctivitis SiccaStudies 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: 901 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03616899
Sponsor's protocol ID: KPI-121-C-011
Acronym: STRIDE 3
Status last verified: Feb 2021
First submitted: 31 Jul 2018
Last updated: 2 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Kerato Conjunctivitis Sicca trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Double-masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle In Subjects With Dry Eye Disease (STRIDE 3)
ClinicalTrials.gov ID: NCT03616899
Acronym / sponsor ID: STRIDE 3 / KPI-121-C-011
Conditions: Kerato Conjunctivitis Sicca
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 901 participants (actual)
Lead sponsor: Kala Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 10 Jul 2018 (actual)
Primary completion: 5 Feb 2020 (actual)
Study completion: 5 Feb 2020 (actual)
First posted: 6 Aug 2018 (actual)
Results: Posted 2 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 0.25% Ophthalmic Suspension	Active comparator	Drug: KPI-121 Ophthalmic Suspension
Vehicle of KPI-121 0.25% Ophthalmic Suspension	Placebo comparator	Drug: Vehicle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (4 listed)

Known hypersensitivity or contraindication to the investigational 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.

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 Ophthalmic SuspensionKPI-121 Ophthalmic Suspension	Drug	KPI-121 0.25% Ophthalmic Suspension
VehicleVehicle for KPI-121 0.25% ophthalmic suspension	Drug	Vehicle of KPI-121 0.25% Ophthalmic Suspension

Primary outcome

Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)
Time frame: Baseline/Visit 2 (Day 1) and to 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.
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
Time frame: Baseline/Visit 2 (Day 1) and to 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, in a sub-group of participants with more severe ocular discomfort at baseline.

5 secondary outcomes

Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
Time frame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor
Time frame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 3 (Day 8)
Time frame: Baseline/Visit 2 (Day 1) to Visit 3 (Day 8)
Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)
Time frame: Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean
Time frame: Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)

Results and safety

Results posted to the registry on 2 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
KPI-121 0.25% Ophthalmic Suspension	447	437
Vehicle of KPI-121 0.25% Ophthalmic Suspension	454	453

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

Time frame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15). Mean (Standard Deviation). Unit: score on a scale

Measure	KPI-121 0.25% Ophthalmic Suspension n = 434	Vehicle of KPI-121 0.25% Ophthalmic Suspension n = 451
Value	-13.58 (19.379)	-8.91 (17.579)

Population analysed: 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

Primary outcome: 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

Time frame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15). Mean (Standard Deviation). Unit: score on a scale

Measure	KPI-121 0.25% Ophthalmic Suspension n = 296	Vehicle of KPI-121 0.25% Ophthalmic Suspension n = 304
Value	-15.59 (20.373)	-10.15 (18.739)

Population analysed: Sub-group of Intent to Treat population with more severe ocular discomfort minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
KPI-121 0.25% Ophthalmic Suspension	3 of 449 (0.7%)	39 of 449 (8.7%)	0 of 449
Vehicle of KPI-121 0.25% Ophthalmic Suspension	1 of 452 (0.2%)	26 of 452 (5.8%)	0 of 452

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

81 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 Ophthalmic Suspension in people with Kerato Conjunctivitis Sicca, run by Kala Pharmaceuticals, Inc. at 81 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 1 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 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 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 2 Apr 2021). 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?

Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) (time frame: Baseline/Visit 2 (Day 1) and to Visit 4 (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?

On the ClinicalTrials.gov record for NCT03616899.

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 2 Apr 2021.