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

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)

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04362670
Enrollment
153
Registered
2020-04-27
Start date
2020-04-23
Completion date
2021-08-11
Last updated
2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

Keywords

Cyclosporine, Intracanalicular insert

Brief 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.

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

Interventions

DRUGOTX-CSI

OTX-CSI intracanalicular insert

OTHERPlacebo Vehicle

Hydrogel Vehicle intracanalicular insert

Sponsors

Ocular Therapeutix, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Subjects With At Least One (1) Treatment Emergent Adverse EventFrom 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 12Change from Baseline at Week 12A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm).

Countries

United States

Participant flow

Participants by arm

ArmCount
OTX-CSI Cohort 1 F2A
This arm was open label and all 5 subjects received F2A OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months)
5
OTX-CSI Cohort 2 F1
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 2-3 months)
42
OTX-CSI Cohort 2 F2A
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months)
41
OTX-CSI Cohort 2 F2B
Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 3-4 months)
43
OTX-CSI Cohort 2 F3
Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 1 week)
22
Total153

Baseline characteristics

CharacteristicOTX-CSI Cohort 2 F1OTX-CSI Cohort 2 F2AOTX-CSI Cohort 2 F2BOTX-CSI Cohort 2 F3OTX-CSI Cohort 1 F2ATotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
26 Participants27 Participants24 Participants14 Participants4 Participants95 Participants
Age, Categorical
Between 18 and 65 years
16 Participants13 Participants19 Participants8 Participants1 Participants57 Participants
Age, Continuous67.9 years
STANDARD_DEVIATION 10.2
68.0 years
STANDARD_DEVIATION 11.5
65.5 years
STANDARD_DEVIATION 10.4
65.2 years
STANDARD_DEVIATION 9.7
73.0 years
STANDARD_DEVIATION 8.1
67.0 years
STANDARD_DEVIATION 10.5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants1 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
6 Participants7 Participants8 Participants2 Participants0 Participants23 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
36 Participants33 Participants34 Participants18 Participants5 Participants126 Participants
Region of Enrollment
North America
42 participants40 participants43 participants22 participants5 participants152 participants
Sex: Female, Male
Female
29 Participants25 Participants39 Participants17 Participants5 Participants115 Participants
Sex: Female, Male
Male
13 Participants15 Participants4 Participants5 Participants0 Participants37 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 50 / 420 / 410 / 430 / 22
other
Total, other adverse events
0 / 515 / 4214 / 415 / 431 / 22
serious
Total, serious adverse events
0 / 51 / 422 / 410 / 430 / 22

Outcome results

Primary

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

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

Time frame: From Screening to Study Exit, approximately 156 days.

ArmMeasureValue (NUMBER)
OTX-CSI Cohort 1 F2ANumber of Subjects With At Least One (1) Treatment Emergent Adverse Event0 count of participants
OTX-CSI Cohort 2 F1Number of Subjects With At Least One (1) Treatment Emergent Adverse Event16 count of participants
OTX-CSI Cohort 2 F2ANumber of Subjects With At Least One (1) Treatment Emergent Adverse Event15 count of participants
OTX-CSI Cohort 2 F2BNumber of Subjects With At Least One (1) Treatment Emergent Adverse Event5 count of participants
OTX-CSI Cohort 2 F3Number of Subjects With At Least One (1) Treatment Emergent Adverse Event1 count of participants
Primary

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).

Time frame: Change from Baseline at Week 12

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

ArmMeasureValue (LEAST_SQUARES_MEAN)
OTX-CSI Cohort 2 F1Schirmer Test Score, CFB at Week 121.98 millimeters
OTX-CSI Cohort 2 F2ASchirmer Test Score, CFB at Week 121.91 millimeters
OTX-CSI Cohort 2 F2BSchirmer Test Score, CFB at Week 122.24 millimeters
OTX-CSI Cohort 2 F3Schirmer Test Score, CFB at Week 123.08 millimeters

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026