Clinical trial NCT01791517: Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions
Official title: Clinical and Laboratory Evaluation of Three Contact Lens Materials With Four Contact Lens Solutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Solutions
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Comfort Score (Senofilcon A Lens)
timeFrame: 2-Week Follow-up
measure: Overall Comfort Score (Galyfilcon A Lens)
timeFrame: 2-Week Follow-up
measure: Overall Comfort Score (Etafilcon A Lens)
timeFrame: 2-Week Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston College of Optometry
state: Texas
city: Waterloo
country: Canada
facility: University of Waterloo Centre for Contact Lens Research School of Optometry
state: Ontario
city: Manchester
country: United Kingdom
facility: University of Manchester, Department of Optometry & Neuroscience
state: Lancashire
Study officials:
References:
citation: 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.
citation: 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.