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OpenTrials
Completed

NCT Number: NCT00813761

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

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aston Triangle, Birmingham, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

O2Optix Contact lens

Device

control contact lens to be worn daily for approximately 7 months for entire length of study.

Proclear contact lens

Device

control contact lens to be worn for entire length of study.

ReNu MultiPlus Multi-Purpose Solution

Device

lens solution for overnight lens disinfection

Clear Care Cleaning and Disinfecting Solution

Device

lens solution for overnight lens disinfection

Primary outcomes

  1. Average Daily Wear Time

    Time frame: 24 weeks

    Average hours per day that contact lens were worn.

  2. Average Daily Comfortable Wear Time

    Time frame: 24 weeks

    Average hours per day that contact lens were worn comfortably.

  3. Lens Comfort

    Time frame: 24 weeks

    Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.

  4. Frequency of Eye Discomfort

    Time frame: 24 weeks

    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.

  5. Frequency of Daily Lens Dryness

    Time frame: 24 weeks

    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.

  6. Frequency of Eye Burning/Stinging

    Time frame: 24 weeks

    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.

  7. Frequency of Itching

    Time frame: 24 weeks

    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.

  8. Frequency of Tearing

    Time frame: 24 weeks

    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.

  9. Average Corneal Fluorescein Type Staining

    Time frame: 24 weeks

    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.

  10. Average Corneal Fluorescein Staining Area

    Time frame: 24 weeks

    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%.

  11. Limbal Redness

    Time frame: 24 weeks

    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

  12. Bulbar Redness

    Time frame: 24 weeks

    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

  13. Lower Tarsal Redness

    Time frame: 24 weeks

    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

  14. Upper Tarsal Redness

    Time frame: 24 weeks

    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

  15. Tarsal Roughness

    Time frame: 24 weeks

    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 outcomes

  1. Intensity of Physiological Outcomes

    Time frame: 24 weeks

    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.

  2. Wearing Time and Comfortable Wearing Time

    Time frame: 24 weeks

    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.

  3. Physiological Responses

    Time frame: 24 weeks

    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).

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 23, 2008
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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