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Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

Primary Purpose

Refractive Error

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delefilcon A Multifocal Contact Lenses with Molded Mark
Delefilcon A Multifocal Contact Lenses
Sponsored by
Alcon, a Novartis Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must sign an Informed Consent document;
  • Current wearer of commercial DAILIES TOTAL1® contact lenses;
  • Have spectacles in current prescription available to be worn in conjunction with the investigational product;
  • Manifest astigmatism less than or equal to 0.75 diopter (D) (at screening)
  • Best corrected distance visual acuity (BCVA) greater than or equal to 20/25 in each eye;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Eye injury in either eye within 12 weeks prior to study enrollment;
  • Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
  • History of herpetic keratitis, refractive surgery or irregular cornea;
  • A pathologically dry eye that precludes contact lens wear;
  • Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
  • Monocular (only 1 eye with functional vision);
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

  • Contact Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DT1 MF MM

DT1 MF

Arm Description

Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours

Delefilcon A multifocal contact lenses worn bilaterally for 9 hours

Outcomes

Primary Outcome Measures

Incidence of Ocular Discomfort Device-related Adverse Events (AE)
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as "Related" to study device and deemed to be related to ocular discomfort.

Secondary Outcome Measures

Ocular Staining
Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis.
Limbal Hyperemia
Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis.

Full Information

First Posted
October 18, 2016
Last Updated
May 31, 2018
Sponsor
Alcon, a Novartis Company
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1. Study Identification

Unique Protocol Identification Number
NCT02939170
Brief Title
Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks
Official Title
Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 14, 2016 (Actual)
Primary Completion Date
December 2, 2016 (Actual)
Study Completion Date
December 2, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon, a Novartis Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the impact of back surface molded marks (MM) applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DT1 MF MM
Arm Type
Experimental
Arm Description
Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours
Arm Title
DT1 MF
Arm Type
Active Comparator
Arm Description
Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
Intervention Type
Device
Intervention Name(s)
Delefilcon A Multifocal Contact Lenses with Molded Mark
Intervention Type
Device
Intervention Name(s)
Delefilcon A Multifocal Contact Lenses
Other Intervention Name(s)
DAILIES TOTAL1® Multifocal (DT1 MF)
Primary Outcome Measure Information:
Title
Incidence of Ocular Discomfort Device-related Adverse Events (AE)
Description
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as "Related" to study device and deemed to be related to ocular discomfort.
Time Frame
Day 1 at Hour 9
Secondary Outcome Measure Information:
Title
Ocular Staining
Description
Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis.
Time Frame
Day 1 at Hour 9
Title
Limbal Hyperemia
Description
Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis.
Time Frame
Day 1 at Hour 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must sign an Informed Consent document; Current wearer of commercial DAILIES TOTAL1® contact lenses; Have spectacles in current prescription available to be worn in conjunction with the investigational product; Manifest astigmatism less than or equal to 0.75 diopter (D) (at screening) Best corrected distance visual acuity (BCVA) greater than or equal to 20/25 in each eye; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Eye injury in either eye within 12 weeks prior to study enrollment; Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear; Any use of systemic or ocular medications for which contact lens wear could be contraindicated; History of herpetic keratitis, refractive surgery or irregular cornea; A pathologically dry eye that precludes contact lens wear; Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days; Monocular (only 1 eye with functional vision); Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, CTM
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

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