Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions

Clinical and Laboratory Evaluation of Three Contact Lens Materials With Four Contact Lens Solutions

The purpose of this study is to evaluate the clinical and laboratory performance of three brand name contact lenses with three recently introduced multipurpose lens care solutions (test solutions) as well as a peroxide disinfecting solution (control solution).

Study Overview

• Status: Completed
• Conditions: Contact Lens Solutions
• Intervention / Treatment: Other: Solution 1 (Test); Other: Solution 2 (Test); Other: Solution 3 (Test); Other: Solution 4 (Control)

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada
      • University of Waterloo Centre for Contact Lens Research School of Optometry
• United Kingdom
  • Lancashire
    • Manchester, Lancashire, United Kingdom
      • University of Manchester, Department of Optometry & Neuroscience
• United States
  • Texas
    • Houston, Texas, United States, 77204
      • University of Houston College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instruction set forth in this clinical protocol.
3. The subject must be between 18 and 69 years of age.
4. The subject must be willing to participate in a 9-month study.
5. The subject must require a visual correction in both eyes.
6. Subjective refraction must result in a vertex-corrected spherical contact lens prescription of +2.00D to -8.00D in each eye.
7. The subject must have best-corrected visual acuity of 0.20 or better in each eye.
8. The subject must be a current wearer of spherical soft contact lenses (no bifocal contact lenses or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
9. The subject must require no more than -1.25D cylindrical correction in each eye after vertexing to the corneal plane.
10. The subject must have normal eye with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.

Exclusion Criteria:

1. Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued).
2. Self-reported adverse reaction to a contact lens solution to be used in the study that in the opinion of the investigator would contraindicate use of that solution.
3. Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
4. Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. equal to or greater than Grade 3 finding of edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the study specific classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.
5. Any active ocular infection.
6. Current use of topical ophthalmic medications.
7. History of binocular vision abnormality or strabismus.
8. More than occasional use of dry eye/rewetting drops (more than 2 times per day on average).
9. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
10. History of severe allergic reaction or anaphylaxis.
11. Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear.
12. Employee of the investigational clinic (e.g. investigator, coordinator, technician)
13. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lens A (senofilcon A); Subjects randomized to Lens A will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).	Other: Solution 1 (Test); Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order; Other Names: Revitalens; Other: Solution 2 (Test); Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order; Other Names: Pure Moist; Other: Solution 3 (Test); Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order; Other Names: Biotrue; Other: Solution 4 (Control); Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order; Other Names: Clear Care
Other: Lens B (galyfilcon A); Subjects randomized to Lens B will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).	Other: Solution 1 (Test); Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order; Other Names: Revitalens; Other: Solution 2 (Test); Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order; Other Names: Pure Moist; Other: Solution 3 (Test); Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order; Other Names: Biotrue; Other: Solution 4 (Control); Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order; Other Names: Clear Care
Other: Lens C (etafilcon A); Subjects randomized to Lens C will be further randomized to 1 of 12 unique solution sequences; each subject will l receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).	Other: Solution 1 (Test); Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order; Other Names: Revitalens; Other: Solution 2 (Test); Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order; Other Names: Pure Moist; Other: Solution 3 (Test); Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order; Other Names: Biotrue; Other: Solution 4 (Control); Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order; Other Names: Clear Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Comfort Score (Senofilcon A Lens)	CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).	2-Week Follow-up
Overall Comfort Score (Galyfilcon A Lens)	CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).	2-Week Follow-up
Overall Comfort Score (Etafilcon A Lens)	CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).	2-Week Follow-up

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Publications and helpful links

General Publications

• Schulze MM, Srinivasan S, Hickson-Curran SB, Berntsen DA, Howarth GF, Toubouti Y, Morgan P, Nichols JJ, Jones LW; Performance of Contact Lens Solutions Study Group. Lid Wiper Epitheliopathy in Soft Contact Lens Wearers. Optom Vis Sci. 2016 Aug;93(8):943-54. doi: 10.1097/OPX.0000000000000919.
• Berntsen DA, Hickson-Curran SB, Jones LW, Mathew JH, Maldonado-Codina C, Morgan PB, Schulze MM, Nichols JJ; Performance of Contact Lens Solutions Study Group. Subjective Comfort and Physiology with Modern Contact Lens Care Products. Optom Vis Sci. 2016 Aug;93(8):809-19. doi: 10.1097/OPX.0000000000000901.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: February 11, 2013
• First Submitted That Met QC Criteria: February 11, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

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

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: CR-5230

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes