Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear

June 26, 2015 updated by: Allergan
Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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:

  • Adapted contact lens wearer

Exclusion Criteria:

  • Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant

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: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Carboxymethylcellulose sodium and Glycerin
Carboxymethylcellulose sodium and Glycerin based rewetting drop
Device: Carboxymethylcellulose sodium and Glycerin
Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
Other Names:
  • Optive™
ACTIVE_COMPARATOR: Carboxymethylcellulose sodium
Carboxymethylcellulose sodium based rewetting drop
Device: Carboxymethylcellulose sodium
Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
Other Names:
  • Refresh Contacts®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity
Time Frame: Change from Baseline at Day 90
Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.
Change from Baseline at Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal Staining
Time Frame: Day 90
Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding
Day 90

Collaborators and Investigators

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

Sponsor

Allergan

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

March 1, 2008

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

March 4, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (ESTIMATE)

June 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 22, 2015

Last Update Submitted That Met QC Criteria

June 26, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG9689-002

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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