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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: O2Optix contact lens; Device: ReNu MultiPlus Multi-Purpose Solution; Device: Proclear contact lens; Device: Clear Care Cleaning and Disinfecting Solution

• Study Type: Interventional
• Enrollment (Actual): 473
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham
    • Aston Triangle, Birmingham, United Kingdom
• United States
  • Arkansas
    • North Little Rock, Arkansas, United States
  • California
    • Campbell, California, United States
    • Cupertino, California, United States
    • Laguna Niguel, California, United States
    • Mission Viejo, California, United States
    • San Clemente, California, United States
  • Colorado
    • Colorado Springs, Colorado, United States
  • Illinois
    • Bloomington, Illinois, United States
  • Kansas
    • Neodesha, Kansas, United States
  • Missouri
    • Raytown, Missouri, United States
    • Warrensburg, Missouri, United States
  • New Jersey
    • Florence, New Jersey, United States
  • Ohio
    • Chagrin Falls, Ohio, United States
    • Warren, Ohio, United States
  • Pennsylvania
    • Kittanning, Pennsylvania, United States
    • Moon, Pennsylvania, United States
    • Nanticoke, Pennsylvania, United States
    • State College, Pennsylvania, United States
  • Rhode Island
    • Warwick, Rhode Island, United States
  • South Dakota
    • Chamberlain, South Dakota, United States
  • Tennessee
    • Bartlett, Tennessee, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Vermont
    • Burlington, Vermont, United States
  • Virginia
    • Midlothian, Virginia, United States
    • Virginia Beach, Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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
OTHER: Proclear CL and ReNu MPS with SICS; Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution	Device: ReNu MultiPlus Multi-Purpose Solution; lens solution for overnight lens disinfection; Device: Proclear contact lens; control contact lens to be worn for entire length of study.
OTHER: 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
OTHER: 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
OTHER: 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
OTHER: Proclear CL and ReNu MPS without SICS; Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution	Device: ReNu MultiPlus Multi-Purpose Solution; lens solution for overnight lens disinfection; Device: Proclear contact lens; control contact lens to be worn for entire length of study.
OTHER: 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2008
• Primary Completion (ACTUAL): August 1, 2009
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: December 17, 2008
• First Submitted That Met QC Criteria: December 22, 2008
• First Posted (ESTIMATE): December 23, 2008

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Pharmaceutical Solutions
• Other Study ID Numbers: CR-4522