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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01791517
First received: February 11, 2013
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention
Contact Lens Solutions
Other: RevitaLens OcuTec
Other: OptiFree PureMoist
Other: Biotrue Multipurpose Solution
Other: Clear Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Clinical and Laboratory Evaluation of Three Contact Lens Materials With Four Contact Lens Solutions

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Patient Reported Comfort using Contact Lens User Experience (CLUE) TM Comfort Domain [ Time Frame: 2 weeks post daily wear ] [ Designated as safety issue: No ]
    Assessment The Contact Lens User Evaluation(CLUE)TM questionnaire 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).


Secondary Outcome Measures:
  • Corneal Staining [ Time Frame: 2 weeks post daily wear ] [ Designated as safety issue: No ]
  • Limbal Conjunctival Redness [ Time Frame: 2 weeks post daily wear ] [ Designated as safety issue: No ]
  • Bulbar Conjunctival Redness [ Time Frame: 2 weeks post daily wear ] [ Designated as safety issue: No ]
  • Tarsal Appearance [ Time Frame: 2 weeks post daily wear ] [ Designated as safety issue: No ]

Enrollment: 269
Study Start Date: February 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
etifilcon A
Worn in a daily wear modality
Other: RevitaLens OcuTec
Each subject, for each lens type will be exposed to each lens care solution in a random order
Other Name: Complete RevitaLens (UK)
Other: OptiFree PureMoist
Each subject, for each lens type will be exposed to each lens care solution in a random order
Other Name: PureMoist (North America and UK)
Other: Biotrue Multipurpose Solution
Each subject, for each lens type will be exposed to each lens care solution in a random order
Other: Clear Care
Each subject, for each lens type will be exposed to each lens care solution in a random order
Other Name: AO Sept Plus (UK)
galyfilcon A
Worn in a daily wear modality
Other: RevitaLens OcuTec
Each subject, for each lens type will be exposed to each lens care solution in a random order
Other Name: Complete RevitaLens (UK)
Other: OptiFree PureMoist
Each subject, for each lens type will be exposed to each lens care solution in a random order
Other Name: PureMoist (North America and UK)
Other: Biotrue Multipurpose Solution
Each subject, for each lens type will be exposed to each lens care solution in a random order
Other: Clear Care
Each subject, for each lens type will be exposed to each lens care solution in a random order
Other Name: AO Sept Plus (UK)
senofilcon A
Worn in a daily wear modality
Other: RevitaLens OcuTec
Each subject, for each lens type will be exposed to each lens care solution in a random order
Other Name: Complete RevitaLens (UK)
Other: OptiFree PureMoist
Each subject, for each lens type will be exposed to each lens care solution in a random order
Other Name: PureMoist (North America and UK)
Other: Biotrue Multipurpose Solution
Each subject, for each lens type will be exposed to each lens care solution in a random order
Other: Clear Care
Each subject, for each lens type will be exposed to each lens care solution in a random order
Other Name: AO Sept Plus (UK)

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01791517

Locations
United States, Texas
Houston, Texas, United States
Canada, Ontario
Waterloo, Ontario, Canada
United Kingdom
Manchester, Lancashire, United Kingdom
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01791517     History of Changes
Other Study ID Numbers: CR-5230
Study First Received: February 11, 2013
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Contact Lens Solutions
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014