Phase 2 N=172 Randomized Double-blind Treatment

To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease

Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT04747977 ↗

Enrolled (actual)

172

Serious AEs

1.2%

Results posted

Feb 2023

Primary outcome: Primary: Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center). — -0.51; -0.43; -0.21 score on a scale

Study Design & Population

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center).	-0.51; -0.43; -0.21	—

Summary

To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease.

Eligibility Criteria

Inclusion Criteria

Dry Eye Disease diagnosis
VAS eye dryness severity score ≥ 40.

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 (NCT04747977). 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.