Dry Eye SyndromesPhase 3STRIDE 1NCT02813265
Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
A Phase 3 study testing KPI-121 0.25% Ophthalmic Suspension in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Kala Pharmaceuticals, Inc. at 60 sites in United States.
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
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- What is being tested?
- KPI-121 0.25% Ophthalmic Suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 918 participants
- Where
- 60 sitesUnited States
- Study dates
- Jun 2016to Oct 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
- 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, 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.
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
United States60 sites
Dixon Eye Care
Albany, Georgia, 31701
Sall Research Medical Center
Artesia, California, 90701
Chu Vision Institute
Bloomington, Minnesota, 55420
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, 33426
Hill Country Eye Center
Cedar Park, Texas, 78613
Mundorf Eye Center
Charlotte, North Carolina, 28204
Lifelong Vision Foundation at Pepose Vision Institute
Chesterfield, Missouri, 63017
Abrams Eye Center
Cleveland, Ohio, 44115
Opthalamic Surgeons & Consultants of Ohio
Columbus, Ohio, 43215
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Firozvi Research, LLC / North Carolina Eye, Ear, Nose & Throat
Durham, North Carolina, 27704
Bergstrom Eye Research
Fargo, North Dakota, 58103
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, 80525
Eye Associates of Fort Myers
Fort Myers, Florida, 33901
Orange County Ophthalmology Medical Group
Garden Grove, California, 92843
The Eye Center of Southern CT, P.C.
Hamden, Connecticut, 06518
Houston Eye Associates
Houston, Texas, 77025
Midwest Cornea Associates, LLC
Indianapolis, Indiana, 46290
United Medical Research Institute
Inglewood, California, 90301
Jacksoneye, S. C.
Lake Villa, Illinois, 60046
Conestoga Eye
Lancaster, Pennsylvania, 17601
Shettle Eye Research, Inc.
Largo, Florida, 33773
Wellish Vision Institute
Las Vegas, Nevada, 89119
Tanner Clinic
Layton, Utah, 84041
The Eye Clinic of Texas, Affiliate of Houston Eye Associates
League City, Texas, 77573
Lake Travis Eye and Laser Center
Leander, Texas, 78641
Eyecare Arkansas, P.A.
Little Rock, Arkansas, 72205
Little Rock Eye Clinic, LLP
Little Rock, Arkansas, 72205
Corneal Consultants of Colorado
Littleton, Colorado, 80209
Apex Eye
Mason, Ohio, 45040
See Clearly Vision
McLean, Virginia, 22102
Total Eye Care, PA
Memphis, Tennessee, 38119
North Valley Eye Medical Group
Mission Hills, California, 91345
Montebello Medical Center, Inc.
Montebello, California, 90640
LoBue Laser and Eye Medical Center
Murrieta, California, 92562
Eye Research Foundation
Newport Beach, California, 92663
Virginia Eye Consultants
Norfolk, Virginia, 23502
Pendleton Eye Center
Oceanside, California, 92056
Stiles EyeCare Excellence and Glaucoma Institute
Overland Park, Kansas, 66213
Atlantic Eye Center
Palm Coast, Florida, 32137
The Eye Center of North Florida
Panama City, Florida, 32405
Matossian Eye Associates
Pennington, New Jersey, 08534
North Bay Eye Associates, Inc.
Petaluma, California, 94954
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, 85032
UPMC Eye Center
Pittsburgh, Pennsylvania, 15213
Eyecare Center
Raleigh, North Carolina, 27603
Martel Eye Medical Group
Rancho Cordova, California, 95670
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Rochester Ophthalmological Group, PC
Rochester, New York, 14618
Roseburg Research Associates, LLC
Roseburg, Oregon, 97471
Sacramento Eye Consultants
Sacramento, California, 95815
Eye Clinics of South Texas
San Antonio, Texas, 78209
R and R Eye Research, LLC
San Antonio, Texas, 78229
Keystone Research - Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Schwartz Laser Eye Center
Scottsdale, Arizona, 85260
Cornea Consultants of Albany
Slingerlands, New York, 12159
Ophthalmology Associates
St Louis, Missouri, 63131
Ophthalmology Consultants, Ltd.
St Louis, Missouri, 63131
South Shore Eye Center, LLP
Wantagh, New York, 11793
Clinical Eye Research of Boston
Winchester, Massachusetts, 01890
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
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
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- Being tested
- KPI-121 0.25% Ophthalmic Suspension, Vehicle of KPI-121 0.25% Ophthalmic Suspension
- Keywords
- Ocular Discomfort, Pain, Corticosteroid, Hyperemia, Dry Eye
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca, Pain, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPI-121 0.25% Ophthalmic SuspensionDrug
Also called Loteprednol etabonate
Vehicle of KPI-121 0.25% Ophthalmic SuspensionDrug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Active comparator | Not described Receives: Drug: KPI-121 0.25% Ophthalmic Suspension |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Placebo comparator | Not described Receives: Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension |
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 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 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) 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) 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 (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
- First posted24 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2017
- Study completionOct 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 Dry Eye SyndromesStudies 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
- 918 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
- NCT02813265
- Sponsor's protocol ID
- KPI-121-C-006
- Acronym
- STRIDE 1
- Status last verified
- Jan 2021
- First submitted
- 21 Jun 2016
- Last updated
- 3 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 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
- ClinicalTrials.gov ID
- NCT02813265
- Acronym / sponsor ID
- STRIDE 1 / KPI-121-C-006
- Conditions
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- Keywords
- Ocular Discomfort, Pain, Corticosteroid, Hyperemia, Dry Eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 918 participants (actual)
- Lead sponsor
- Kala Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Posted 3 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
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 0.25% Ophthalmic Suspension |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Placebo comparator | Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension |
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, 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.
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 0.25% Ophthalmic SuspensionAlso: Loteprednol etabonate | Drug | KPI-121 0.25% Ophthalmic Suspension |
| Vehicle of KPI-121 0.25% Ophthalmic SuspensionAlso: Placebo | Drug | Vehicle of KPI-121 0.25% Ophthalmic Suspension |
Primary outcome
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)
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.
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) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)
Time frame: Baseline/Visit 2 (Day 1) and to 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.
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.
9 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)
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)
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)
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)
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.
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)
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
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
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)
Time frame: Visit 4 (Day 15)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 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.
60 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 0.25% Ophthalmic Suspension in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Kala Pharmaceuticals, Inc. at 60 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 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 3 Dec 2020). 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 Bulbar Conjunctival Hyperemia at Visit 4 (Day 15) (time frame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)). The study lists 4 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 3 Feb 2021.