Comparison of Two Daily Disposable Soft Contact Lenses
A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
1 other identifier
interventional
55
1 country
1
Brief Summary
The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedStudy Start
First participant enrolled
February 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2019
CompletedResults Posted
Study results publicly available
October 8, 2020
CompletedOctober 8, 2020
September 1, 2020
6 months
December 13, 2018
August 25, 2020
September 14, 2020
Conditions
Outcome Measures
Primary Outcomes (8)
Lens Fit - Horizontal Centration
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Baseline
Lens Fit - Horizontal Centration
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
One Week
Lens Fit - Vertical Centration
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Baseline
Lens Fit - Vertical Centration
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
One Week
Lens Fit - Corneal Coverage
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Baseline
Lens Fit - Corneal Coverage
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
One Week
Lens Fit - Lens Movement
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Baseline
Lens Fit - Lens Movement
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
One Week
Secondary Outcomes (2)
Subjective Score for Vision
Baseline
Subjective Score for Vision
One week
Study Arms (2)
midafilcon A
ACTIVE COMPARATORSubjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
somofilcon A
ACTIVE COMPARATORSubjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
Interventions
Eligibility Criteria
You may qualify if:
- They are between 18 and 40 years of age (inclusive).
- They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
- They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
- They own a wearable pair of spectacles and wear them on the day of the initial visit.
- At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
- They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
- They agree not to participate in other clinical research for the duration of the study.
You may not qualify if:
- They have an ocular disorder, which would normally contra-indicate contact lens wear.
- They have a systemic disorder, which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- They are pregnant or breastfeeding.
- They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear
- They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CooperVision Inc.
Pleasanton, California, 94588, United States
Results Point of Contact
- Title
- Jose A. Vega, O.D, MSc., FAAO
- Organization
- CooperVision. Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Morgan, PhD MCOptom FAAO FBCLA
Eurolens Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
December 13, 2018
First Posted
December 19, 2018
Study Start
February 8, 2019
Primary Completion
July 30, 2019
Study Completion
September 18, 2019
Last Updated
October 8, 2020
Results First Posted
October 8, 2020
Record last verified: 2020-09