Study to Evaluate a Contact Lens Lubricating and Rewetting Drop

September 29, 2020 updated by: Bausch & Lomb Incorporated

Study to Evaluate the Product Feasibility of a Contact Lens Lubricating and Rewetting Drop

The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

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

  • United States
    • New York
      • Rochester, New York, United States, 14609
        • Bausch & Lomb

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  • Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
  • Use a lens care system on a regular basis.
  • Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day.
  • Willing to use drops 4 times per day.

Exclusion Criteria:

  • Participating in a conflicting study.
  • An active ocular disease, any corneal infiltrative response, or are using any ocular medications.
  • Any scar or neovascularization within the central 4mm of the cornea.
  • Any grade 2 or greater finding during the slit lamp examination
  • Using any systemic or topical medications that will affect ocular physiology or lens performance.
  • Aphakic.
  • Amblyopic.
  • Allergic to any component in the study care products.
  • Have had any corneal surgery.

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: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lubricating and Rewetting Drops
Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.
Device: Lubricating and Rewetting Drops
Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.
Active Comparator: AMO Blink Contacts Lubricant Eye Drops
AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week
Device: AMO Blink Contacts Lubricant Eye Drops
Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.
Time Frame: At 1 week follow up
Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding > grade 2, across abnormalities.
At 1 week follow up

Collaborators and Investigators

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

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Principal Investigator: Stephanie Su, OD, Bausch & Lomb Incorporated

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

October 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 27, 2010

First Submitted That Met QC Criteria

December 27, 2010

First Posted (Estimate)

December 28, 2010

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 29, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 684E

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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