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Clinical Evaluation of Two Monthly Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03459131
Recruitment Status : Completed
First Posted : March 8, 2018
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.

Condition or disease Intervention/treatment Phase
Refractive Errors Device: Comfilcon A with Digital Zone Optics™ contact lenses Device: Comfilcon A contact lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Two Monthly Contact Lenses
Actual Study Start Date : March 7, 2018
Actual Primary Completion Date : March 26, 2018
Actual Study Completion Date : March 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
BIOFINITY ENERGYS then BIOFINITY
Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
Device: Comfilcon A with Digital Zone Optics™ contact lenses
Silicone hydrogel spherical contact lenses with Digital Zone Optics™
Other Name: BIOFINITY® ENERGYS™

Device: Comfilcon A contact lenses
Silicone hydrogel spherical contact lenses
Other Name: BIOFINITY®

BIOFINITY then BIOFINITY ENERGYS
Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
Device: Comfilcon A with Digital Zone Optics™ contact lenses
Silicone hydrogel spherical contact lenses with Digital Zone Optics™
Other Name: BIOFINITY® ENERGYS™

Device: Comfilcon A contact lenses
Silicone hydrogel spherical contact lenses
Other Name: BIOFINITY®




Primary Outcome Measures :
  1. Subjective Rating of Overall Vision [ Time Frame: Day 7, each product ]
    Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.


Secondary Outcome Measures :
  1. Over-refraction [ Time Frame: Day 1 (Dispense), each product ]
    Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to understand and sign an approved informed consent form (ICF);
  • Successful wear of BIOFINITY® (spherical) (or private label) contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
  • Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
  • Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
  • Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
  • Refractive, ocular, or intraocular surgery, as specified in the protocol;
  • Current or history of eye injury or disorders, as specified in the protocol;
  • Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
  • Habitual contact lens wear in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
  • Use of topical ocular medications that would require instillation during contact lens wear;
  • Other protocol-specified exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459131


Locations
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United States, Florida
Alcon Investigative Site
Maitland, Florida, United States, 32751
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon, A Novartis Division Alcon, A Novartis Division
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] March 1, 2018
Statistical Analysis Plan  [PDF] March 1, 2018


Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03459131     History of Changes
Other Study ID Numbers: CLD523-E001
First Posted: March 8, 2018    Key Record Dates
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases