Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Comparison of Two Daily Disposable Soft 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: NCT03518008
Recruitment Status : Completed
First Posted : May 8, 2018
Results First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.

Condition or disease Intervention/treatment Phase
Myopia Refractive Errors Device: verofilcon A contact lenses Device: somofilcon A contact lenses Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Actual Study Start Date : May 23, 2018
Actual Primary Completion Date : June 11, 2018
Actual Study Completion Date : June 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
DD T2, then Clariti 1 Day
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality.
Device: verofilcon A contact lenses
Investigational daily disposable soft contact lenses
Other Name: DD T2

Device: somofilcon A contact lenses
Commercially available daily disposable soft contact lenses
Other Names:
  • clariti® 1 day
  • Clariti 1 Day

Clariti 1 Day, then DD T2
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality.
Device: verofilcon A contact lenses
Investigational daily disposable soft contact lenses
Other Name: DD T2

Device: somofilcon A contact lenses
Commercially available daily disposable soft contact lenses
Other Names:
  • clariti® 1 day
  • Clariti 1 Day




Primary Outcome Measures :
  1. Overall Quality of Vision [ Time Frame: Day 8, each product ]
    Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Understand and sign an Informed Consent Form;
  • Successful wear of daily disposable spherical soft 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;
  • Willing to stop wearing habitual contact lenses for the duration of study participation;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator;
  • Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
  • Refractive, ocular, or intraocular surgery, as specified in the protocol;
  • Eye condition or injury, as specified in the protocol;
  • Current or history of intolerance, hypersensitivity, or allergy to any component of the study products;
  • Wearing habitual contact lenses 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 and artificial tear or rewetting drops requiring instillation during contact lens wear;
  • Currently wearing clariti® 1 day contact lenses;
  • Habitually wearing monovision or multifocal lenses during the last 3 months;
  • 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): NCT03518008


Locations
Layout table for location information
United States, Florida
Alcon Investigative Site
Maitland, Florida, United States, 32751
Sponsors and Collaborators
Alcon Research
Investigators
Layout table for investigator information
Study Director: Alcon Research Alcon Research
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] April 20, 2018
Statistical Analysis Plan  [PDF] April 30, 2018


Additional Information:
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03518008     History of Changes
Other Study ID Numbers: CLE383-C006
First Posted: May 8, 2018    Key Record Dates
Results First Posted: April 3, 2019
Last Update Posted: April 3, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Alcon Research:
soft contact lenses
vision
eyesight
Additional relevant MeSH terms:
Layout table for MeSH terms
Refractive Errors
Eye Diseases