Clinical Evaluation of the Long‑Term Effects of Contact Lens Care Systems

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00813761
First received: December 17, 2008
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.


Condition Intervention
Myopia
Device: O2Optix contact lens
Device: Proclear contact lens
Device: ReNu MultiPlus Multi-Purpose Solution
Device: Clear Care Cleaning and Disinfecting Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Average Daily Wear Time [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Average hours per day that contact lens were worn.

  • Average Daily Comfortable Wear Time [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Average hours per day that contact lens were worn comfortably.

  • Lens Comfort [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.

  • Frequency of Eye Discomfort [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Frequency of Daily Lens Dryness [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Frequency of Eye Burning/Stinging [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Frequency of Itching [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Frequency of Tearing [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Average Corneal Fluorescein Type Staining [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Average Corneal Fluorescein Staining Area [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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%.

  • Limbal Redness [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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

  • Bulbar Redness [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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

  • Lower Tarsal Redness [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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

  • Upper Tarsal Redness [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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

  • Tarsal Roughness [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Intensity of Physiological Outcomes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible to "Solution Induced Corneal Staining (SICS)". These measures are related to intensity of outcomes, i.e. discomfort, burning, dryness, etc. with lower scores being better on a scale of 1-5. Scores were measured for 1 min to 5 min maximum.

  • Wearing Time and Comfortable Wearing Time [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for "Solution Induced Corneal Staining (SICS)". Average wearing time and average comfortable wearing time.

  • Physiological Responses [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for "Solution Induced Corneal Staining (SICS)". Physiological findings are done through a slit lamp examination and are known as biomicroscopy measurements. Measures are given in terms of average score with a minimum of zero and a worse grade the higher the value with a range of 0 to 4, (tarsal roughness is 0-7 scale).


Enrollment: 473
Study Start Date: September 2008
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
02Optix CL and ReNu MPS with SICS
O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
Device: O2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.
Device: ReNu MultiPlus Multi-Purpose Solution
lens solution for overnight lens disinfection
Proclear CL and ReNu MPS with SICS
Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
Device: Proclear contact lens
control contact lens to be worn for entire length of study.
Device: ReNu MultiPlus Multi-Purpose Solution
lens solution for overnight lens disinfection
02Optix CL and Clear Care LCS with SICS
O2Optix contact lens and Clear Care lens care solution subject
Device: O2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.
Device: Clear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection
Proclear CL and Clear Care LCS with SICS
Proclear contact lens and Clear Care lens care solution
Device: Proclear contact lens
control contact lens to be worn for entire length of study.
Device: Clear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection
02Optix CL and ReNu MPS without SICS
O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
Device: O2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.
Device: ReNu MultiPlus Multi-Purpose Solution
lens solution for overnight lens disinfection
Proclear CL and ReNu MPS without SICS
Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
Device: Proclear contact lens
control contact lens to be worn for entire length of study.
Device: ReNu MultiPlus Multi-Purpose Solution
lens solution for overnight lens disinfection
02Optix CL and Clear Care LCS without SICS
O2Optix contact lens and Clear Care lens care solution
Device: O2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.
Device: Clear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection
Proclear CL and Clear Care LCS without SICS
Proclear contact lens and Clear Care lens care solution
Device: Proclear contact lens
control contact lens to be worn for entire length of study.
Device: Clear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813761

  Show 26 Study Locations
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00813761     History of Changes
Other Study ID Numbers: CR-4522
Study First Received: December 17, 2008
Results First Received: October 24, 2011
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014