Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-01-31

Brief Summary

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

To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.

Related Clinical Trials

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

Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms

NCT00399061

Dry Eye

COMPLETED PHASE4

Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy

NCT02121847

Dry Eye Syndromes

COMPLETED PHASE4

Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

NCT00611403

Dry Eye Syndromes

COMPLETED PHASE2

Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye

NCT01319773

Dry Eye Syndromes

COMPLETED PHASE1

Efficacy and Acceptability of Two Lubricant Eye Drops

NCT00756678

Dry Eye Syndromes

COMPLETED PHASE4

Detailed Description

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

Conditions

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

Dry Eye

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

A

Group Type OTHER

Restasis, Optive Tears

Intervention Type DRUG

Restasis and Optive Tears use twice daily more frequently if needed

Interventions

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

Restasis, Optive Tears

Restasis and Optive Tears use twice daily more frequently if needed

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* · Males or females \> 18 years old

* Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye.
* Likely to complete all study visits and able to provide informed consent

Exclusion Criteria

* · Patients using Restasis® for less than 3 months.

* Known contraindications to any study medication or ingredients
* Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
* Other active uncontrolled ocular diseases or uncontrolled systemic disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No