Artificial Tears Study in Mild to Moderate Dry Eye Patients

February 5, 2008 updated by: Abbott Medical Optics
The mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild to moderate dry eye
  • over 18

Exclusion Criteria:

  • No concurrent ocular disease or meds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Systane
Drug: Systane
Drops
EXPERIMENTAL: 2
Blink tears
Drug: (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400
Drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subjective ocular comfort
Time Frame: 1 Month
1 Month

Secondary Outcome Measures

Outcome Measure
Time Frame
Vision quality
Time Frame: 1 Month
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Optics

Investigators

  • Principal Investigator: Eric Donnenfeld, M.D., Ophthalmic Consultants of Long Island

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

February 5, 2008

First Posted (ESTIMATE)

February 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 6, 2008

Last Update Submitted That Met QC Criteria

February 5, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEGT-104-9582

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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