- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00995189
Clinical Evaluation of the Causes of Contact Lens Related Dry Eye
November 15, 2016 updated by: Alcon Research
A Clinical Evaluation of the Causes of Soft Contact Lens Related Dry Eye
The purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Daily wear soft contact lens wearers reporting significant contact lens-related dryness symptoms were enrolled.
Late day dryness with contact lenses, intensity grade 3-5, frequency "sometimes / frequently / constantly" as evaluated by a questionnaire was considered significant.
Study Type
Interventional
Enrollment (Actual)
159
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
-
-
Texas
-
Fort Worth, Texas, United States, 76134
- Contact Alcon Call Center for Trial 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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Reports late-day dryness symptoms with contact lens wear on questionnaire.
- Wears FDA Group 2 hydrogel, FDA Group 4 hydrogel, or silicone hydrogel lenses.
- Consistently uses either polyhexamethylene biguanide (PHMB) or polyquaternium-1 (PQT) contact lens care products (i.e. >6 months including 1 month immediately before enrollment).
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Wears daily disposable contact lenses.
- Has significant symptoms related to lens fit or lens deposits.
- Requires concurrent ocular medication (rewetting drops allowed).
- Has used Restasis® in the last 3 months.
- Wears punctal plugs fitted in the last 30 days.
- Has any current systemic or ocular abnormality, infection or disease.
- Uses any current systemic medication likely to affect tear film, e.g. antihistamines, betaadrenergic blockers, steroids.
- Has a history of refractive surgery.
- Other protocol-defined exclusion criteria may apply.
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: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: OFR
Opti-Free RepleniSH contact lens care solution used for 30 days
|
Contact lens care solution containing polyquaternium-1 (PQT)
Daily wear, frequent replacement contact lenses per participant's habitual brand and power.
|
ACTIVE_COMPARATOR: RNM
ReNu MultiPlus contact lens care solution used for 30 days
|
Daily wear, frequent replacement contact lenses per participant's habitual brand and power.
Contact lens care solution containing polyhexamethylene biguanide (PHMB)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjective Dryness
Time Frame: 2 weeks, one month
|
2 weeks, one month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
corneal staining
Time Frame: 2 weeks, one month
|
2 weeks, one month
|
conjunctival staining
Time Frame: two weeks, one month
|
two weeks, one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
August 1, 2009
Primary Completion (ACTUAL)
April 1, 2010
Study Completion (ACTUAL)
April 1, 2010
Study Registration Dates
First Submitted
October 14, 2009
First Submitted That Met QC Criteria
October 14, 2009
First Posted (ESTIMATE)
October 15, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
November 17, 2016
Last Update Submitted That Met QC Criteria
November 15, 2016
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-09-03 / DRYS 1302 / IBIS
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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