Efficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints

September 26, 2013 updated by: Optometric Technology Group Ltd

Evaluation of the Effect of Repeated Usage of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints

The objectives of the investigation will be to assess the effect of the repeated usage of a new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with contact lens related comfort problems and to quantify any potential benefit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 4

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 Kingdom
      • London, United Kingdom, SW1E 6AU
        • OTG Research & Consultancy

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:

  • Current silicone hydrogel contact lens wearer
  • Complaints of contact lens related dry eye (Symptoms and reduced comfortable wearing time)

Exclusion criteria:

  • Known allergy or sensitivity to the study product(s) or its components
  • Systemic or ocular allergies
  • Use of systemic medication which might have ocular side effects.
  • Any ocular infection.
  • Use of ocular medication.
  • Significant ocular tissue anomaly

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: New study eye drop
One month of contact lens wear with use of the Test study eye drops
Device: OPTIVEtm Plus
1 drop in each eye four times a day for a period of 30 (± 3) days
Placebo Comparator: No Eyedrop
One month of contact lens wear with no eye drop use
Procedure: No treatment
One month of contact lens wear with no eye drop use
Active Comparator: BLINK Contacts Lubricating eye drop
One month of contact lens wear with use of the Control study eye drops
Device: Blink Contacts® Eye Drops
1 drop in each eye four times a day for a period of 30 (± 3) days
Other Names:
  • Blink Contacts®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tear Break up Time
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Conjunctival staining measurement
Time Frame: 30 days
30 days
Tear film evaporation rate
Time Frame: 30 days
30 days
Ocular Surface Disease Index questionnaire
Time Frame: 30 days
30 days
Comfort, vision and ocular symptoms questionnaire
Time Frame: 30 days
30 days
Post wear contact lens deposition and lipid uptake assessment
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Optometric Technology Group Ltd

Collaborators

Allergan

Investigators

  • Principal Investigator: Michel Guillon, PhD, Optometric Technology Group Ltd

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

February 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

February 27, 2012

First Posted (Estimate)

March 2, 2012

Study Record Updates

Last Update Posted (Estimate)

September 27, 2013

Last Update Submitted That Met QC Criteria

September 26, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG9965-006 ID 11-19

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.

Clinical Trials on Contact Lens Related Dry Eye Syndrome

Clinical Trials on OPTIVEtm Plus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe