CompletedNCT02813265STRIDE 1Updated Feb 3, 2021Results posted

Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease

A Phase 3 interventional study of KPI-121 0.25% Ophthalmic Suspension and Vehicle of KPI-121 0.25% Ophthalmic Suspension in Dry Eye Syndromes and Keratoconjunctivitis Sicca, sponsored by Kala Pharmaceuticals, Inc.. Completed at 60 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-03.

Primary conditionKeratoconjunctivitis SiccaRegistry: Dry Eye SyndromesReclassifiedWhy we changed it

Registry

Dry Eye Syndromes — the first condition term the registry derived for this study.

ClinicalTrials.gg

Keratoconjunctivitis Sicca

Why

The study's listed conditions name Keratoconjunctivitis Sicca, a narrower term within Dry Eye Syndromes.

Confidence

High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →

Wrong?

Tell us the study's main condition →

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

Phase: Phase 3
Study type: Interventional
Enrollment: 918
Allocation: Randomized
Ages: 18 Years and older
Sex: All

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.

Conditions studied

Dry Eye Syndromes
Keratoconjunctivitis Sicca

Browse trials for

Dry Eye Syndromes 1,366Registry's first term
Keratoconjunctivitis Sicca 85Primary · reclassified
Pain 10,054
Hyperemia 98

Keywords

Ocular Discomfort
Pain
Corticosteroid
Hyperemia
Dry Eye

In context

Keratoconjunctivitis Sicca Reclassified

85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.

This study's enrollment of 918 is above the median of 82 across 75 interventional studies indexed under Keratoconjunctivitis Sicca.

Browse Keratoconjunctivitis Sicca studies →

Lead sponsor

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 →

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, 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; 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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 918 participants (actual)

Study arms

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

Interventions

DrugKPI-121 0.25% Ophthalmic Suspension
Also known as: Loteprednol etabonate
DrugVehicle of KPI-121 0.25% Ophthalmic Suspension
Also known as: Placebo

What researchers measure

Primary outcomes

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

Secondary outcomes

Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1)
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)
Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at Visit 4 (Day 15)
Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores. 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)
Change From Baseline/Visit 2 (Day 1) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal)
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)
Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1)
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 3 (Day 8)
Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus Baseline/Visit 2 (Day 1) 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.
Time frame: Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
Change in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1)
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 3 (Day 8)
Change in Ocular Discomfort Severity Scores on Day 4 Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) 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 3 (Day 8)
Change From Baseline/Visit 2 (Day 1) in Conjunctival Hyperemia Scores With a Day 1 Conjunctival Hyperemia Score of ≥ 2 in the Subgroup of Participants With More Severe Ocular Discomfort
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 in a sub-group of participants with more severe ocular discomfort at baseline.. 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)
Subjects With a Grade of 0 in Conjunctival Hyperemia Score 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: Visit 4 (Day 15)

Results

Posted Dec 3, 2020

Participant flow

Participant flow — Overall Study
Milestone	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension
Started	459	456
Completed	455	453
Not completed	4	3

Outcome measures

PrimaryChange 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 scale	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension
Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)	-0.4049 ± 0.65062	-0.1574 ± 0.60704

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 scale	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)	-14.53 ± 20.636	-9.16 ± 17.924

PrimaryChange 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) and 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 scale	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension
Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)	-0.5 ± 0.84	-0.4 ± 0.79

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

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 scale	KPI-121 0.25% Ophthalmic Suspension	Vehicle 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	-16.67 ± 21.937	-10.76 ± 18.037

SecondaryChange in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1)

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) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1)
score on a scale	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension
Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1)	-0.4648 ± 0.66770	-0.2045 ± 0.62567

SecondaryProportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at Visit 4 (Day 15)

Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores. 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:: Count of participants · Participants

Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at Visit 4 (Day 15)
Participants	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension
Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at Visit 4 (Day 15)	189	98

SecondaryChange From Baseline/Visit 2 (Day 1) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal)

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) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal)
score on a scale	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension
Change From Baseline/Visit 2 (Day 1) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal)	-0.2980 ± 0.59018	-0.0421 ± 0.51921

SecondaryChange in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1)

Time frame:: Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
Reported as:: Mean · score on a scale

Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1)
score on a scale	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension
Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1)	-8.12 ± 16.880	-4.81 ± 14.851

SecondaryChange in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort.

Time frame:: Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
Reported as:: Mean · score on a scale

Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort.
score on a scale	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension
Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort.	-9.90 ± 17.835	-6.38 ± 15.289

SecondaryChange in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1)

Time frame:: Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
Reported as:: Mean · score on a scale

Change in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1)
score on a scale	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension
Change in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1)	-6.60 ± 16.710	-3.20 ± 15.125

SecondaryChange in Ocular Discomfort Severity Scores on Day 4 Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort

Time frame:: Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
Reported as:: Mean · score on a scale

Change in Ocular Discomfort Severity Scores on Day 4 Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort
score on a scale	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension
Change in Ocular Discomfort Severity Scores on Day 4 Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort	-8.48 ± 17.412	-5.20 ± 14.903

SecondaryChange From Baseline/Visit 2 (Day 1) in Conjunctival Hyperemia Scores With a Day 1 Conjunctival Hyperemia Score of ≥ 2 in the Subgroup of Participants With More Severe Ocular Discomfort

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 in a sub-group of participants with more severe ocular discomfort at baseline.. 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 Conjunctival Hyperemia Scores With a Day 1 Conjunctival Hyperemia Score of ≥ 2 in the Subgroup of Participants With More Severe Ocular Discomfort
score on a scale	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension
Change From Baseline/Visit 2 (Day 1) in Conjunctival Hyperemia Scores With a Day 1 Conjunctival Hyperemia Score of ≥ 2 in the Subgroup of Participants With More Severe Ocular Discomfort	-0.47 ± 0.631	-0.22 ± 0.577

SecondarySubjects With a Grade of 0 in Conjunctival Hyperemia Score at Visit 4 (Day 15)

Time frame:: Visit 4 (Day 15)
Reported as:: Count of participants · Participants

Subjects With a Grade of 0 in Conjunctival Hyperemia Score at Visit 4 (Day 15)
Participants	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension
Subjects With a Grade of 0 in Conjunctival Hyperemia Score at Visit 4 (Day 15)	27	16

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
Group	Deaths	Serious	Other
KPI-121 0.25% Ophthalmic Suspension	0/459 (0%)	0/459 (0%)	66/459 (14.4%)
Vehicle of KPI-121 0.25% Ophthalmic Suspension	0/456 (0%)	0/456 (0%)	62/456 (13.6%)

Most frequent other events

Showing 10 of 54

Most frequent other events
Event	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension
Installation site painGeneral disorders	28/459	28/456
Eye IrritationEye disorders	5/459	7/456
Conjunctival hyperemiaEye disorders	2/459	4/456
Foreign Body SensationEye disorders	2/459	4/456
Eye PruritusEye disorders	1/459	4/456
Instillation site pruritusGeneral disorders	1/459	3/456
NasopharyngitisInfections and infestations	0/459	3/456
BlepharitisEye disorders	3/459	0/456
Lacrimination increasedEye disorders	3/459	2/456
Intraocular pressure increasedInvestigations	3/459	1/456

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension	Total
Mean	58.1 ± 15.41	58.3 ± 14.66	58.2 ± 15.03

Sex: Female, Male
Sex: Female, Male(Participants)	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension	Total
Female	367	359	726
Male	92	97	189

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension	Total
American Indian or Alaska Native	2	0	2
Asian	18	18	36
Native Hawaiian or Other Pacific Islander	1	1	2
Black or African American	69	71	140
White	362	361	723
More than one race	1	1	2
Unknown or Not Reported	6	4	10

Region of Enrollment
Region of Enrollment(participants)	KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension	Total
United States	459	456	915

Study locations

60 sites

Cornea and Cataract Consultants of Arizona
Phoenix, Arizona 85032, United States
Schwartz Laser Eye Center
Scottsdale, Arizona 85260, United States
Eyecare Arkansas, P.A.
Little Rock, Arkansas 72205, United States
Little Rock Eye Clinic, LLP
Little Rock, Arkansas 72205, United States
Sall Research Medical Center
Artesia, California 90701, United States
Orange County Ophthalmology Medical Group
Garden Grove, California 92843, United States
United Medical Research Institute
Inglewood, California 90301, United States
North Valley Eye Medical Group
Mission Hills, California 91345, United States
Montebello Medical Center, Inc.
Montebello, California 90640, United States
LoBue Laser and Eye Medical Center
Murrieta, California 92562, United States
Eye Research Foundation
Newport Beach, California 92663, United States
Pendleton Eye Center
Oceanside, California 92056, United States
North Bay Eye Associates, Inc.
Petaluma, California 94954, United States
Martel Eye Medical Group
Rancho Cordova, California 95670, United States
Sacramento Eye Consultants
Sacramento, California 95815, United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado 80525, United States
Corneal Consultants of Colorado
Littleton, Colorado 80209, United States
The Eye Center of Southern CT, P.C.
Hamden, Connecticut 06518, United States
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida 33426, United States
Eye Associates of Fort Myers
Fort Myers, Florida 33901, United States
Shettle Eye Research, Inc.
Largo, Florida 33773, United States
Atlantic Eye Center
Palm Coast, Florida 32137, United States
The Eye Center of North Florida
Panama City, Florida 32405, United States
Dixon Eye Care
Albany, Georgia 31701, United States
Jacksoneye, S. C.
Lake Villa, Illinois 60046, United States
Midwest Cornea Associates, LLC
Indianapolis, Indiana 46290, United States
Stiles EyeCare Excellence and Glaucoma Institute
Overland Park, Kansas 66213, United States
Clinical Eye Research of Boston
Winchester, Massachusetts 01890, United States
Chu Vision Institute
Bloomington, Minnesota 55420, United States
Lifelong Vision Foundation at Pepose Vision Institute
Chesterfield, Missouri 63017, United States
Ophthalmology Associates
Saint Louis, Missouri 63131, United States
Ophthalmology Consultants, Ltd.
Saint Louis, Missouri 63131, United States
Wellish Vision Institute
Las Vegas, Nevada 89119, United States
Matossian Eye Associates
Pennington, New Jersey 08534, United States
Rochester Ophthalmological Group, PC
Rochester, New York 14618, United States
Cornea Consultants of Albany
Slingerlands, New York 12159, United States
South Shore Eye Center, LLP
Wantagh, New York 11793, United States
Mundorf Eye Center
Charlotte, North Carolina 28204, United States
Firozvi Research, LLC / North Carolina Eye, Ear, Nose & Throat
Durham, North Carolina 27704, United States
Eyecare Center
Raleigh, North Carolina 27603, United States
Bergstrom Eye Research
Fargo, North Dakota 58103, United States
Abrams Eye Center
Cleveland, Ohio 44115, United States
Opthalamic Surgeons & Consultants of Ohio
Columbus, Ohio 43215, United States
Apex Eye
Mason, Ohio 45040, United States
Roseburg Research Associates, LLC
Roseburg, Oregon 97471, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania 16066, United States
Conestoga Eye
Lancaster, Pennsylvania 17601, United States
UPMC Eye Center
Pittsburgh, Pennsylvania 15213, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota 57701, United States
Total Eye Care, PA
Memphis, Tennessee 38119, United States
Hill Country Eye Center
Cedar Park, Texas 78613, United States
Houston Eye Associates
Houston, Texas 77025, United States
The Eye Clinic of Texas, Affiliate of Houston Eye Associates
League City, Texas 77573, United States
Lake Travis Eye and Laser Center
Leander, Texas 78641, United States
Eye Clinics of South Texas
San Antonio, Texas 78209, United States
R and R Eye Research, LLC
San Antonio, Texas 78229, United States
Keystone Research - Medical Center Ophthalmology Associates
San Antonio, Texas 78240, United States
Tanner Clinic
Layton, Utah 84041, United States
See Clearly Vision
McLean, Virginia 22102, United States
Virginia Eye Consultants
Norfolk, Virginia 23502, United States

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Jul 6, 2017

PDFs hosted by the registry, ClinicalTrials.gov.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02813265
Lead sponsor: Kala Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Jun 24, 2016
Start date: Jun 2016
Primary completion: Oct 2017
Completion: Oct 2017
Results posted: Dec 3, 2020
Last update: Feb 3, 2021

Oversight

Data monitoring committee: No

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Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Loteprednol Etabonate

Other studies in this condition

Keratoconjunctivitis Sicca →

Other studies from this sponsor

Kala Pharmaceuticals, Inc.

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