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

Not Applicable

Completed

• Conditions: Contact Lens Solutions
• Interventions: Other: Solution 1 (Test); Other: Solution 2 (Test); Other: Solution 3 (Test); Other: Solution 4 (Control)

• Registration Number: NCT01791517
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-01
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-15
• Primary Completion: 2014-02-01
• Study Completion: 2014-02-01
• Results First Submitted: 2017-08-16
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-05
• Results First Posted: 2017-11-06
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lens A (senofilcon A)	Solution 3 (Test)	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)).
Lens B (galyfilcon A)	Solution 4 (Control)	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)).
Lens A (senofilcon A)	Solution 1 (Test)	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)).
Lens A (senofilcon A)	Solution 4 (Control)	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)).
Lens B (galyfilcon A)	Solution 1 (Test)	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)).
Lens C (etafilcon A)	Solution 3 (Test)	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)).
Lens A (senofilcon A)	Solution 2 (Test)	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)).
Lens B (galyfilcon A)	Solution 3 (Test)	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)).
Lens C (etafilcon A)	Solution 2 (Test)	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)).
Lens C (etafilcon A)	Solution 4 (Control)	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)).
Lens B (galyfilcon A)	Solution 2 (Test)	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)).
Lens C (etafilcon A)	Solution 1 (Test)	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)).

Primary Outcome Measures

Name	Time	Method
Overall Comfort Score (Senofilcon A Lens)	2-Week Follow-up	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).
Overall Comfort Score (Galyfilcon A Lens)	2-Week Follow-up	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).
Overall Comfort Score (Etafilcon A Lens)	2-Week Follow-up	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).

Trial Locations

Locations (3)

University of Houston College of Optometry; 🇺🇸 Houston, Texas, United States

University of Waterloo Centre for Contact Lens Research School of Optometry; 🇨🇦 Waterloo, Ontario, Canada

University of Manchester, Department of Optometry & Neuroscience; 🇬🇧 Manchester, Lancashire, United Kingdom