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

• Sponsor: Ocular Therapeutix, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04362670
• Collaborator: (none)
• Enrollment: 153
• Locations: 15
• Arms: 5
• Actual Duration (Months): 15.6
• Patients Per Site: 10.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: OTX-CSI; Other: Placebo Vehicle	Phase 1/Phase 2

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• 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 studiesSequential: 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 (Participant, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Apr 23, 2020
• Actual Primary Completion Date: Aug 11, 2021
• Actual Study Completion Date: Aug 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OTX-CSI-Cohort 1 Formulation 2A-.36 mg	Drug: OTX-CSI; OTX-CSI intracanalicular insert
Experimental: OTX-CSI-Cohort 2 Formulation 1- .36 mg	Drug: OTX-CSI; OTX-CSI intracanalicular insert
Placebo Comparator: HV Cohort 2: Formulation 2B	Other: Placebo Vehicle; Hydrogel Vehicle intracanalicular insert
Experimental: OTX-CSI- Cohort 2 Formulation 2A- .36 mg	Drug: OTX-CSI; OTX-CSI intracanalicular insert
Placebo Comparator: HV-2 Cohort 2: Formulation 3	Other: Placebo Vehicle; Hydrogel Vehicle intracanalicular insert

Outcome Measures

Primary Outcome Measures

1. Incidence of treatment emergent adverse events for each subject [Through study completion, an average of 1 year]

   All adverse events will be captured throughout the study

2. Efficacy outcome measures [Absolute value and change from baseline at week 12]

   Schirmer test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ocular Therapeutix, Inc.	Garden Grove	California	United States	92843
2	Ocular Therapeutix, Inc.	Inglewood	California	United States	90301
3	Ocular Therapeutix, Inc.	Mission Hills	California	United States	91345
4	Ocular Therapeutix, Inc.	Delray Beach	Florida	United States	33484
5	Ocular Therapeutix, Inc.	Largo	Florida	United States	33773
6	Ocular Therapeutix, Inc.	Lake Villa	Illinois	United States	60046
7	Ocular Therapeutix, Inc.	Kansas City	Missouri	United States	64111
8	Ocular Therapeutix, Inc	Saint Louis	Missouri	United States	63128
9	Ocular Therapeutix	Saint Louis	Missouri	United States	63131
10	Ocular Therapeutix, Inc.	Cleveland	Ohio	United States	44115
11	Ocular Therapeutix, Inc.	Cranberry Township	Pennsylvania	United States	16066
12	Ocular Therapeutix, Inc.	Memphis	Tennessee	United States	38119
13	Ocular Therapeutix, Inc.	El Paso	Texas	United States	79902
14	Ocular Therapeutix	Lakeway	Texas	United States	78738
15	Ocular Therapeutix, Inc.	Murray	Utah	United States	84107

Sponsors and Collaborators

• Ocular Therapeutix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ocular Therapeutix, Inc.
• ClinicalTrials.gov Identifier: NCT04362670
• Other Study ID Numbers: CLN-Protocol-0054
• First Posted: Apr 27, 2020
• Last Update Posted: Dec 16, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ocular Therapeutix, Inc.: Cyclosporine; Intracanalicular insert
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases

Study Results

No Results Posted as of Dec 16, 2021