Phase 2 N=153 Randomized Double-blind Treatment

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

Dry Eye Disease

Bottom Line

View on ClinicalTrials.gov: NCT04362670 ↗

Enrolled (actual)

153

Serious AEs

2.0%

Results posted

Nov 2023

Primary outcome: Primary: Number of Subjects With At Least One (1) Treatment Emergent Adverse Event — 0; 16; 15; 5 count of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: OTX-CSI (Drug); Placebo Vehicle (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ocular Therapeutix, Inc.
Primary completion: Aug 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With At Least One (1) Treatment Emergent Adverse Event	0; 16; 15; 5; 1	—
PRIMARY Schirmer Test Score, CFB at Week 12	1.98; 1.91; 2.24; 3.08	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04362670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.