Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems
1 other identifier
interventional
473
2 countries
26
Brief Summary
The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2008
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 17, 2008
CompletedFirst Posted
Study publicly available on registry
December 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
November 24, 2011
CompletedJune 19, 2018
June 1, 2017
11 months
December 17, 2008
October 24, 2011
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (15)
Average Daily Wear Time
Average hours per day that contact lens were worn.
24 weeks
Average Daily Comfortable Wear Time
Average hours per day that contact lens were worn comfortably.
24 weeks
Lens Comfort
Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.
24 weeks
Frequency of Eye Discomfort
Subjective measure of typical daily eye discomfort reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
24 weeks
Frequency of Daily Lens Dryness
Subjective measure of typical daily contact lens dryness reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
24 weeks
Frequency of Eye Burning/Stinging
Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
24 weeks
Frequency of Itching
Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
24 weeks
Frequency of Tearing
Subjective measure of typical daily tearing related to lens wear reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
24 weeks
Average Corneal Fluorescein Type Staining
staining measured over five sectors of the cornea and classified as a type of staining on a scale of 0 to 4. 0=None, 1=Micropunctate, 2=Macropunctate, 3=Coalesced Macropunctate, 4=Patch.
24 weeks
Average Corneal Fluorescein Staining Area
corneal staining measured over 5 areas, averaged, and graded as a single score average on a scale of 0 to 10, 0=0%, 1=10%, 2=20%, 3=30%, 4=40%, 5=50%, 6=60%, 7=70%, 8=80%, 9=90%, 10=100%.
24 weeks
Limbal Redness
Redness at the transition zone between the white of the eye and the clear window of the eye, the cornea, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
24 weeks
Bulbar Redness
Redness of the blood vessels in the tissues overlaying the white of the eye, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
24 weeks
Lower Tarsal Redness
Redness of the blood vessels in the inner lining of the lower eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
24 weeks
Upper Tarsal Redness
Redness of the blood vessels in the inner lining of the upper eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
24 weeks
Tarsal Roughness
The roughness of the inner lining of the eyelids, measured on a 0 to 7 scale. 0=Smooth, 1=Slightly uneven, 2=Uneven surface, 3=Uneven surface with loss of transparency \& superficial vessels, 4=Small papillae, poor transparency, 5=Papillae greater than 0.5mm in size, no transparency, 6=Papillae greater than 0.5mm in size, vessels inside papillae, 7=Large papillae
24 weeks
Secondary Outcomes (3)
Intensity of Physiological Outcomes
24 weeks
Wearing Time and Comfortable Wearing Time
24 weeks
Physiological Responses
24 weeks
Study Arms (8)
02Optix CL and ReNu MPS with SICS
OTHERO2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
Proclear CL and ReNu MPS with SICS
OTHERProclear contact lens and ReNu MultiPlus Multi-Purpose Solution
02Optix CL and Clear Care LCS with SICS
OTHERO2Optix contact lens and Clear Care lens care solution subject
Proclear CL and Clear Care LCS with SICS
OTHERProclear contact lens and Clear Care lens care solution
02Optix CL and ReNu MPS without SICS
OTHERO2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
Proclear CL and ReNu MPS without SICS
OTHERProclear contact lens and ReNu MultiPlus Multi-Purpose Solution
02Optix CL and Clear Care LCS without SICS
OTHERO2Optix contact lens and Clear Care lens care solution
Proclear CL and Clear Care LCS without SICS
OTHERProclear contact lens and Clear Care lens care solution
Interventions
control contact lens to be worn daily for approximately 7 months for entire length of study.
control contact lens to be worn for entire length of study.
lens solution for overnight lens disinfection
lens solution for overnight lens disinfection
Eligibility Criteria
You may qualify if:
- Be at least 18 years old.
- Signed Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
- Require a visual correction in both eyes (monovision allowed but not monofit).
- Have a contact lens spherical distance requirement between +6.00D and -9.00D in both eyes.
- Astigmatism of 1.00D or less in the better eye and 1.50D or less in the other eye.
- Be correctable to a visual acuity of 20/30 (6/9) or better in each eye.
- Have normal eyes with no evidence of abnormality or disease.
You may not qualify if:
- Requires concurrent ocular medication.
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Clinically significant corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
- Worn lenses on an extended wear basis in the last 3 months.
- Diabetic.
- Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
- Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
- Abnormal lacrimal secretions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
North Little Rock, Arkansas, United States
Unknown Facility
Campbell, California, United States
Unknown Facility
Cupertino, California, United States
Unknown Facility
Laguna Niguel, California, United States
Unknown Facility
Mission Viejo, California, United States
Unknown Facility
San Clemente, California, United States
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Bloomington, Illinois, United States
Unknown Facility
Neodesha, Kansas, United States
Unknown Facility
Raytown, Missouri, United States
Unknown Facility
Warrensburg, Missouri, United States
Unknown Facility
Florence, New Jersey, United States
Unknown Facility
Chagrin Falls, Ohio, United States
Unknown Facility
Warren, Ohio, United States
Unknown Facility
Kittanning, Pennsylvania, United States
Unknown Facility
Moon Township, Pennsylvania, United States
Unknown Facility
Nanticoke, Pennsylvania, United States
Unknown Facility
State College, Pennsylvania, United States
Unknown Facility
Warwick, Rhode Island, United States
Unknown Facility
Chamberlain, South Dakota, United States
Unknown Facility
Bartlett, Tennessee, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Burlington, Vermont, United States
Unknown Facility
Midlothian, Virginia, United States
Unknown Facility
Virginia Beach, Virginia, United States
Unknown Facility
Aston Triangle, Birmingham, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kristy Canavan, OD
- Organization
- Vistakon
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2008
First Posted
December 23, 2008
Study Start
September 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
June 19, 2018
Results First Posted
November 24, 2011
Record last verified: 2017-06