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A Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye

NCT07068958 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-16

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and efficacy of 0.25% RCI001 Ophthalmic Solution twice a day (BID) and four times a day (QID) compared to placebo (vehicle) in the treatment of the signs and symptoms of dry eye.

The secondary objective of this study is to evaluate the optimal dosing frequency of 0.25% RCI001 Ophthalmic Solution (BID versus QID) in the treatment of the signs and symptoms of dry eye.

Conditions

  • Dry Eye Disease (DED)

Interventions

DRUG

0.25% RCI001 Ophthalmic Solution

0.25% RCI001 Ophthalmic Solution

DRUG

Placebo Ophthalmic Solution (vehicle)

Placebo Ophthalmic Solution (vehicle)

Sponsors & Collaborators

  • ORA, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-11-01
Completion
2025-11-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07068958 on ClinicalTrials.gov