Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 1
1 other identifier
interventional
92
1 country
5
Brief Summary
The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Acuvue Moist contact lenses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedStudy Start
First participant enrolled
May 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2019
CompletedResults Posted
Study results publicly available
June 25, 2020
CompletedJune 25, 2020
June 1, 2020
2 months
March 22, 2019
May 29, 2020
June 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Least Squares Mean Distance Visual Acuity With Study Lenses
Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Day 8, each product
Study Arms (2)
DDT2, then 1DAVM
OTHERVerofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
1DAVM, then DDT2
OTHEREtafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
Interventions
Investigational daily disposable soft contact lenses
Commercially available daily disposable soft contact lenses
Eligibility Criteria
You may qualify if:
- Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.
- Willing and able to attend all scheduled study visits as required per protocol.
- Current wearer of spherical soft contact lenses.
You may not qualify if:
- Any ocular condition that contraindicates contact lens wear.
- Previous or current habitual wearer of ACUVUE® MOIST or DAILIES TOTAL1® contact lenses.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (5)
Alcon Investigative Site
Jacksonville, Florida, 32256, United States
Alcon Investigative Site
Maitland, Florida, 32751, United States
Alcon Investigative Site
Orlando, Florida, 32803, United States
Alcon Investigative Site
Powell, Ohio, 43065, United States
Alcon Investigative Site
Memphis, Tennessee, 38111, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- CDMA Project Lead, Vision Care
- Organization
- Alcon Research, LLC
Study Officials
- STUDY DIRECTOR
CDMA Project Lead, Vision Care
Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2019
First Posted
March 25, 2019
Study Start
May 3, 2019
Primary Completion
June 24, 2019
Study Completion
June 24, 2019
Last Updated
June 25, 2020
Results First Posted
June 25, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share