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

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813761
• Other study ID #: CR-4522
• Status: Completed
• Phase: N/A
• Start date: September 1, 2008
• Est. completion date: August 1, 2009

Study information

• Verified date: June 2017
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: August 1, 2009
• Est. primary completion date: August 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• O2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.
• Proclear contact lens
control contact lens to be worn for entire length of study.
• ReNu MultiPlus Multi-Purpose Solution
lens solution for overnight lens disinfection
• Clear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Daily Wear Time	Average hours per day that contact lens were worn.	24 weeks
Primary	Average Daily Comfortable Wear Time	Average hours per day that contact lens were worn comfortably.	24 weeks
Primary	Lens Comfort	Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.	24 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Intensity of Physiological Outcomes	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.	24 weeks
Secondary	Wearing Time and Comfortable Wearing Time	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.	24 weeks
Secondary	Physiological Responses	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).	24 weeks