Dry Eye DiseasePhase 2NCT04084483
A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease
A Phase 2 study testing K-161 in people with Dry Eye Disease, run by Kowa Research Institute, Inc. at 4 sites in United States.
Trial summary
The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing regimen of K-161 in adult subjects with moderate to severe dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- K-161
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Aug 2019to 9 Jan 2020
- Phase
- Phase 2
- 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
- Be at least 18 years of age at the time of informed consent visit.
- Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptoms.
- Meet all inclusion criteria outlined in the clinical study protocol.
Who cannot join
- Have any clinically significant ocular condition.
- Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months.
- Must not meet any other exclusion criteria outlined in the clinical study protocol.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Central Maine Eye Care
Lewiston, Maine, 04240
Total Eye Care, P.A.
Memphis, Tennessee, 38119
Eye Research Foundation
Newport Beach, California, 92663
About this study
The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing regimen of K-161 in adult subjects with moderate to severe dry eye disease.
- Conditions
- Dry Eye Disease
- Being tested
- K-161, Placebo (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.
K-161Drug
K-161 alternate dosage
Placebo (Vehicle)Other
Placebo solution
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | K-161 Ophthalmic Solution Dose A. Receives: Drug: K-161 |
| Group 2 | Experimental | K-161 Ophthalmic Solution Dose B. Receives: Drug: K-161 |
| Group 3 | Experimental | K-161 Ophthalmic Solution Dose C. Receives: Drug: K-161 |
| Group 4 | Placebo comparator | Vehicle Solution Dose. Receives: Other: Placebo (Vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-Controlled Adverse Environment (CAE))
Fluorescein Staining is measured with the Ora Calibra® Corneal and Conjunctival Staining Scale which is a 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining.
K-161 compared to Vehicle. When study patients are exposed to Controlled Adverse Environment (CAE) in terms of relative humidity, temperature, airflow, and visual tasking, the ocular surface is stressed to react. This controlled environmental stress creates a consistent response that's reproducible over time.
Measured: Baseline to Day 29
Change in Ocular Discomfort Scale Post-CAE
Ocular discomfort scores were subjectively graded by the subjects using the Ora Calibra® Ocular Discomfort Scale from 0 to 4 where 0 = No Discomfort and 4 = Constant Discomfort.
Measured: Baseline to Day 29
Secondary outcomes (13)
Change in Schirmer's Test Value (Unanesthetized) Pre-CAE
Measured with Schirmer's test strip with the length of the moistened area recorded in mm. Lower values indicate less tears produced in the eye.
Measured: Baseline to Day 29
Change in Tear Film Break-up Time (TFBUT) Post-CAE
Measured: Baseline to Day 29
Change in Fluorescein Staining Scores (Pre-CAE®)
Fluorescein Staining is measured with the Ora Calibra® Corneal and Conjunctival Staining Scale which is a 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining.
Measured: Baseline to Day 29
Change in Lissamine Green Staining (Pre-CAE) Using the Ora Calibra® Scale (Conjunctival Sum)
Ora Calibra Scale which is 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining.
Measured: Baseline to Day 29
Change in Conjunctival Redness (Pre-CAE)
Conjunctival Redness Scale ranges from 0 to 4, where 0 = normal, without vasodilation and 4 = Broad Ciliary and Prominent, Horizontal Conjunctival Vasodilation. Higher scores indicate worsening conjunctival redness.
Measured: Baseline to Day 29
Change in Tear Film Break-Up Time (Pre CAE)
Measured: Baseline to Day 29
Change in Tear Osmolarity (Pre CAE)
Measured: Baseline to Day 29
Change in Unanesthetized Schirmer's Test (Pre CAE)
Measured with Schirmer's test strip with the length of the moistened area recorded in mm. Lower values indicate less tears produced in the eye.
Measured: Baseline to Day 29
Change in Blink Rate (Pre CAE)
Blinks per 60 seconds.
Measured: Baseline to Day 29
Change in Ocular Discomfort Scale (Pre CAE)
Ora Calibra® Ocular Discomfort Scale ranging from 0 to 4
Measured: Baseline to Day 29
Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE)
Scores ranging from 0 to 5. A score of 0 indicates no discomfort/symptoms and a score of 5 indicates worst discomfort/symptoms.
Measured: Baseline to Day 29
Change in Visual Analog Scale (Pre CAE)
The length of the assessment line was 100 mm; a measure of 0 mm corresponded to "no discomfort" and 100 mm corresponds to "maximal discomfort".
Measured: Baseline to Day 29
Change in Ocular Surface Disease Index Score (Pre-CAE) - Total OSDI
The OSDI© is comprised of 12 questions, with each question assessed on a scale ranging from 0 to 4 where 0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, and 4 = all of the time. The range of total score is "0 to 100". "Subscale" scores are not reported. Higher score represents a worsen outcome. The total score is the sum of subscales.
Measured: Baseline to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start4 Aug 2019
- Primary completion9 Jan 2020
- Study completion9 Jan 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 Dry Eye DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084483
- Sponsor's protocol ID
- K-161-2.01US
- Status last verified
- Feb 2023
- First submitted
- 13 Aug 2019
- Last updated
- 15 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04084483
- Acronym / sponsor ID
- K-161-2.01US
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2019 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 9 Jan 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Posted 15 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing regimen of K-161 in adult subjects with moderate to severe 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: K-161K-161 Ophthalmic Solution Dose A. |
| Group 2 | Experimental | Drug: K-161K-161 Ophthalmic Solution Dose B. |
| Group 3 | Experimental | Drug: K-161K-161 Ophthalmic Solution Dose C. |
| Group 4 | Placebo comparator | Other: Placebo (Vehicle)Vehicle Solution Dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be at least 18 years of age at the time of informed consent visit.
- Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptoms.
- Meet all inclusion criteria outlined in the clinical study protocol.
Key exclusion criteria (3 listed)
- Have any clinically significant ocular condition.
- Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months.
- Must not meet any other exclusion criteria outlined in the clinical study protocol.
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 |
|---|---|---|
| K-161K-161 alternate dosage | Drug | Group 1, Group 2, Group 3 |
| Placebo (Vehicle)Placebo solution | Other | Group 4 |
Primary outcome
Change in Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-Controlled Adverse Environment (CAE))
Time frame: Baseline to Day 29
Fluorescein Staining is measured with the Ora Calibra® Corneal and Conjunctival Staining Scale which is a 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining. K-161 compared to Vehicle. When study patients are exposed to Controlled Adverse Environment (CAE) in terms of relative humidity, temperature, airflow, and visual tasking, the ocular surface is stressed to react. This controlled environmental stress creates a consistent response that's reproducible over time.
Change in Ocular Discomfort Scale Post-CAE
Time frame: Baseline to Day 29
Ocular discomfort scores were subjectively graded by the subjects using the Ora Calibra® Ocular Discomfort Scale from 0 to 4 where 0 = No Discomfort and 4 = Constant Discomfort.
13 secondary outcomes
Change in Schirmer's Test Value (Unanesthetized) Pre-CAE
Time frame: Baseline to Day 29
Change in Tear Film Break-up Time (TFBUT) Post-CAE
Time frame: Baseline to Day 29
Change in Fluorescein Staining Scores (Pre-CAE®)
Time frame: Baseline to Day 29
Change in Lissamine Green Staining (Pre-CAE) Using the Ora Calibra® Scale (Conjunctival Sum)
Time frame: Baseline to Day 29
Change in Conjunctival Redness (Pre-CAE)
Time frame: Baseline to Day 29
Change in Tear Film Break-Up Time (Pre CAE)
Time frame: Baseline to Day 29
Change in Tear Osmolarity (Pre CAE)
Time frame: Baseline to Day 29
Change in Unanesthetized Schirmer's Test (Pre CAE)
Time frame: Baseline to Day 29
Change in Blink Rate (Pre CAE)
Time frame: Baseline to Day 29
Change in Ocular Discomfort Scale (Pre CAE)
Time frame: Baseline to Day 29
Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE)
Time frame: Baseline to Day 29
Change in Visual Analog Scale (Pre CAE)
Time frame: Baseline to Day 29
Change in Ocular Surface Disease Index Score (Pre-CAE) - Total OSDI
Time frame: Baseline to Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing K-161 in people with Dry Eye Disease, run by Kowa Research Institute, Inc. at 4 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 3 inclusion and 3 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 Mar 2023). 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 in Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-Controlled Adverse Environment (CAE)) (time frame: Baseline to Day 29). 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?
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 15 Mar 2023.