Evaluation of the Long Term Follow up of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2019-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this safety long-term follow-up study was to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study (NCT03636061).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease

NCT03636061

Dry Eye Disease

COMPLETED PHASE2

Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease

NCT04036292

Dry Eye Disease (DED)

COMPLETED PHASE3

Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation

NCT03688802

Dry Eye Disease

COMPLETED PHASE2

A Randomized, Controlled, Double-masked, Investigator-initiated Trial to Evaluate Tear Film Quality and Stability in Subjects With Dry Eye Disease Using OC-01 (Varenicline Solution) Nasal Spray 0.03 mg as Compared to Vehicle Control Nasal Spray

NCT05514041

Dry Eye Disease

UNKNOWN PHASE4

Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)

NCT03452397

Dry Eye Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study OPP-002-01 was a long-term follow-up study of those subjects who had previously participated in the OPP-002 study (NCT03636061). The OPP-002 study is a Phase 2, multicenter, randomized, double-masked, placebo-controlled study designed to evaluate the safety and efficacy of OC-01 nasal spray in adult participants with dry eye disease.

The first scheduled visit occurs 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study. The second scheduled visit occurs 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Long Term Follow up Dry Eye Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OC-01 Low Dose, 0.12 mg/mL

OC-01 (varenicline) nasal spray, 0.12 mg/mL

Group Type ACTIVE_COMPARATOR

OC-01 Low Dose, 0.12 mg/mL

Intervention Type DRUG

OC-01 (varenicline) nasal spray

OC-01 Mid Dose, 0.6 mg/mL

OC-01 (varenicline) nasal spray, 0.60 mg/mL

Group Type ACTIVE_COMPARATOR

OC-01 Mid Dose, 0.6 mg/mL

Intervention Type DRUG

OC-01 (varenicline) nasal spray

OC-01 High Dose, 1.2 mg/mL

OC-01 (varenicline) nasal spray, 1.2 mg/mL

Group Type ACTIVE_COMPARATOR

OC-01 High Dose, 1.2 mg/mL

Intervention Type DRUG

OC-01 (varenicline) nasal spray

Placebo (vehicle) nasal spray

Group Type PLACEBO_COMPARATOR

Placebo (vehicle) nasal spray

Intervention Type DRUG

Placebo (vehicle) nasal spray

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OC-01 Low Dose, 0.12 mg/mL

OC-01 (varenicline) nasal spray

Intervention Type DRUG

OC-01 Mid Dose, 0.6 mg/mL

OC-01 (varenicline) nasal spray

Intervention Type DRUG

OC-01 High Dose, 1.2 mg/mL

OC-01 (varenicline) nasal spray

Intervention Type DRUG

Placebo (vehicle) nasal spray

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

OC-01 (varenicline) nasal spray, 0.12 mg/ml OC-01 Mid Dose, 1.2 mg/mL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Have been enrolled in the OPP-002 study
2. Have received at least one dose of the study drug/placebo in OPP-002 study
3. Completed the OPP-002 study to Visit 5
4. Have provided verbal and written informed consent