Dry Eye DiseasePhase 1/2NCT04362670

Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.

A Phase 1/2 study testing OTX-CSI in people with Dry Eye Disease, run by Ocular Therapeutix, Inc. at 15 sites in United States.

Completed

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

Official record

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Trial summary

To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with 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?: OTX-CSI
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 153 participants
Where: 15 sitesUnited States
Study dates: 23 Apr 2020to 11 Aug 2021
Phase: Phase 1/2
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

Dry eye disease diagnosis
VAS eye dryness severity score ≥ 30.

Who cannot join

Are unwilling to discontinue use of contact lenses
Are unwilling to withhold use of artificial tears.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Ocular Therapeutix, Inc.
Cleveland, Ohio, 44115
Ocular Therapeutix, Inc.
Cranberry Township, Pennsylvania, 16066
Ocular Therapeutix, Inc.
Delray Beach, Florida, 33484
Ocular Therapeutix, Inc.
El Paso, Texas, 79902
Ocular Therapeutix, Inc.
Garden Grove, California, 92843
Ocular Therapeutix, Inc.
Inglewood, California, 90301
Ocular Therapeutix, Inc.
Kansas City, Missouri, 64111
Ocular Therapeutix, Inc.
Lake Villa, Illinois, 60046
Ocular Therapeutix
Lakeway, Texas, 78738
Ocular Therapeutix, Inc.
Largo, Florida, 33773
Ocular Therapeutix, Inc.
Memphis, Tennessee, 38119
Ocular Therapeutix, Inc.
Mission Hills, California, 91345
Ocular Therapeutix, Inc.
Murray, Utah, 84107
Ocular Therapeutix, Inc
St Louis, Missouri, 63128
Ocular Therapeutix
St Louis, Missouri, 63131

Other trials in United States

About this study

Official title: A Randomized, Multi-center, Double-masked, Vehicle-controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI (Cyclosporine Ophthalmic Insert) for Intracanalicular Use for the Treatment of Subjects With Dry Eye Disease (DED)

To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.

Read the detailed description

Randomized, multi-center, double-masked, vehicle-controlled, Phase 1/2 study to evaluate the safety, tolerability, and efficacy of OTX-CSI in subjects with dry eye disease. The subjects will be followed for approximately 16 weeks after product insertion

Conditions: Dry Eye Disease
Being tested: OTX-CSI, Placebo Vehicle
Keywords: Cyclosporine, Intracanalicular insert
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.

OTX-CSIDrug
OTX-CSI intracanalicular insert
Placebo VehicleOther
Hydrogel Vehicle intracanalicular insert

Study groups in NCT04362670
Study group	Role	What they receive
OTX-CSI-Cohort 1	Experimental	Formulation 2A-.36 mg Receives: Drug: OTX-CSI
OTX-CSI-Cohort 2	Experimental	Formulation 1- .36 mg Receives: Drug: OTX-CSI
HV	Placebo comparator	Cohort 2: Formulation 2B Receives: Other: Placebo Vehicle
OTX-CSI- Cohort 2	Experimental	Formulation 2A- .36 mg Receives: Drug: OTX-CSI
HV-2	Placebo comparator	Cohort 2: Formulation 3 Receives: Other: Placebo Vehicle

What is being measured

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

Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
Measured: From Screening to Study Exit, approximately 156 days.
Schirmer Test Score, CFB at Week 12
A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm).
Measured: Change from Baseline at Week 12

Timeline

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

23 Apr 202011 Aug 2021

First posted27 Apr 2020
Study start23 Apr 2020
Primary completion11 Aug 2021
Study completion11 Aug 2021

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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Sequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04362670
Sponsor's protocol ID: CLN-Protocol-0054
Status last verified: Oct 2023
First submitted: 16 Apr 2020
Last updated: 14 Nov 2023
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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Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multi-center, Double-masked, Vehicle-controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI (Cyclosporine Ophthalmic Insert) for Intracanalicular Use for the Treatment of Subjects With Dry Eye Disease (DED)
ClinicalTrials.gov ID: NCT04362670
Acronym / sponsor ID: CLN-Protocol-0054
Conditions: Dry Eye Disease
Keywords: Cyclosporine, Intracanalicular insert
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
Study start: 23 Apr 2020 (actual)
Primary completion: 11 Aug 2021 (actual)
Study completion: 11 Aug 2021 (actual)
First posted: 27 Apr 2020 (actual)
Results: Posted 14 Nov 2023

Clinical summary

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

To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 5
Model description: Sequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies

Arm	Type	Receives
OTX-CSI-Cohort 1	Experimental	Drug: OTX-CSIFormulation 2A-.36 mg
OTX-CSI-Cohort 2	Experimental	Drug: OTX-CSIFormulation 1- .36 mg
HV	Placebo comparator	Other: Placebo VehicleCohort 2: Formulation 2B
OTX-CSI- Cohort 2	Experimental	Drug: OTX-CSIFormulation 2A- .36 mg
HV-2	Placebo comparator	Other: Placebo VehicleCohort 2: Formulation 3

Who may qualify

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

Key inclusion criteria (2 listed)

Dry eye disease diagnosis
VAS eye dryness severity score ≥ 30.

Key exclusion criteria (2 listed)

Are unwilling to discontinue use of contact lenses
Are unwilling to withhold use of artificial tears.

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
OTX-CSIOTX-CSI intracanalicular insert	Drug	OTX-CSI- Cohort 2, OTX-CSI-Cohort 1, OTX-CSI-Cohort 2
Placebo VehicleHydrogel Vehicle intracanalicular insert	Other	HV, HV-2

Primary outcome

Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
Time frame: From Screening to Study Exit, approximately 156 days.
Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
Schirmer Test Score, CFB at Week 12
Time frame: Change from Baseline at Week 12
A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm).

Results and safety

Results posted to the registry on 14 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OTX-CSI Cohort 1 F2A	5	5
OTX-CSI Cohort 2 F1	42	39
OTX-CSI Cohort 2 F2A	41	39
OTX-CSI Cohort 2 F2B	43	42
OTX-CSI Cohort 2 F3	22	22

Primary outcome: Number of Subjects With At Least One (1) Treatment Emergent Adverse Event

Time frame: From Screening to Study Exit, approximately 156 days.. Number. Unit: count of participants

Measure	OTX-CSI Cohort 1 F2A n = 5	OTX-CSI Cohort 2 F1 n = 42	OTX-CSI Cohort 2 F2A n = 41	OTX-CSI Cohort 2 F2B n = 43	OTX-CSI Cohort 2 F3 n = 22
Value	0	16	15	5	1

Primary outcome: Schirmer Test Score, CFB at Week 12

Time frame: Change from Baseline at Week 12. Least squares mean (95% Confidence Interval). Unit: millimeters

Measure	OTX-CSI Cohort 1 F2A n = 0	OTX-CSI Cohort 2 F1 n = 42	OTX-CSI Cohort 2 F2A n = 40	OTX-CSI Cohort 2 F2B n = 43	OTX-CSI Cohort 2 F3 n = 22
Value	–	1.98 (0.04 to 3.92)	1.91 (-0.01 to 3.82)	2.24 (0.38 to 4.10)	3.08 (0.51 to 5.65)

Population analysed: Cohort 1 was not included in this analysis, as Cohort 1 was evaluated for Safety only.

Adverse events

Time frame: approximately 156 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OTX-CSI Cohort 1 F2A	0 of 5 (0%)	0 of 5 (0%)	0 of 5
OTX-CSI Cohort 2 F1	1 of 42 (2.4%)	15 of 42 (35.7%)	0 of 42
OTX-CSI Cohort 2 F2A	2 of 41 (4.9%)	14 of 41 (34.1%)	0 of 41
OTX-CSI Cohort 2 F2B	0 of 43 (0%)	5 of 43 (11.6%)	0 of 43
OTX-CSI Cohort 2 F3	0 of 22 (0%)	1 of 22 (4.5%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 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.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OTX-CSI in people with Dry Eye Disease, run by Ocular Therapeutix, Inc. at 15 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 2 inclusion and 2 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 14 Nov 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?

Number of Subjects With At Least One (1) Treatment Emergent Adverse Event (time frame: From Screening to Study Exit, approximately 156 days.). 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 NCT04362670.

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 14 Nov 2023.