Back to resultsClinical Evaluation of the Causes of Contact Lens Related Dry Eye
Primary Purpose
Contact Lens Related Dry Eye
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opti-Free RepleniSH
ReNu MultiPlus
Contact lenses
Sponsored by
About this trial
This is an interventional supportive care trial for Contact Lens Related Dry Eye focused on measuring contact lens wear, multi-purpose solution, corneal staining
Eligibility Criteria
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.
Sites / Locations
- Contact Alcon Call Center For Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OFR
RNM
Arm Description
Opti-Free RepleniSH contact lens care solution used for 30 days
ReNu MultiPlus contact lens care solution used for 30 days
Outcomes
Primary Outcome Measures
Subjective Dryness
Secondary Outcome Measures
corneal staining
conjunctival staining
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00995189
Brief Title
Clinical Evaluation of the Causes of Contact Lens Related Dry Eye
Official Title
A Clinical Evaluation of the Causes of Soft Contact Lens Related Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Lens Related Dry Eye
Keywords
contact lens wear, multi-purpose solution, corneal staining
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OFR
Arm Type
Experimental
Arm Description
Opti-Free RepleniSH contact lens care solution used for 30 days
Arm Title
RNM
Arm Type
Active Comparator
Arm Description
ReNu MultiPlus contact lens care solution used for 30 days
Intervention Type
Device
Intervention Name(s)
Opti-Free RepleniSH
Intervention Description
Contact lens care solution containing polyquaternium-1 (PQT)
Intervention Type
Device
Intervention Name(s)
ReNu MultiPlus
Intervention Description
Contact lens care solution containing polyhexamethylene biguanide (PHMB)
Intervention Type
Device
Intervention Name(s)
Contact lenses
Intervention Description
Daily wear, frequent replacement contact lenses per participant's habitual brand and power.
Primary Outcome Measure Information:
Title
Subjective Dryness
Time Frame
2 weeks, one month
Secondary Outcome Measure Information:
Title
corneal staining
Time Frame
2 weeks, one month
Title
conjunctival staining
Time Frame
two weeks, one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Contact Alcon Call Center For Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27391535
Citation
Chalmers RL, Young G, Kern J, Napier L, Hunt C. Soft Contact Lens-Related Symptoms in North America and the United Kingdom. Optom Vis Sci. 2016 Aug;93(8):836-47. doi: 10.1097/OPX.0000000000000927.
Results Reference
result
Learn more about this trial
Clinical Evaluation of the Causes of Contact Lens Related Dry Eye
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