Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05166902
Other study ID # EX-MKTG-130
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 31, 2022
Est. completion date July 9, 2022

Study information

Verified date May 2022
Source Coopervision, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for 1-month.


Description:

This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different FRP lens types. Each lens type will be worn for approximately one month.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date July 9, 2022
Est. primary completion date July 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: 1. Is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer; 2. Has read and signed an information consent letter; 3. Is willing and able to follow instructions and maintain the appointment schedule; 4. Self-reports having a full eye examination in the previous two years; 5. Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone; 6. Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator; 7. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week; 8. Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: The habitual contact lens brand was restricted such that no more than one third were to be Biofinity Energys brand (or their equivalent private label brand name) and no more than one third were to be Alcon brand); 9. Has refractive astigmatism no higher than -0.75DC in each eye; 10. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps). Exclusion Criteria: 1. Is participating in any concurrent clinical or research study; 2. Has any known active ocular disease and/or infection that contraindicates contact lens wear; 3. Has a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable; 4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; 5. Has known sensitivity to the diagnostic sodium fluorescein used in the study; 6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; 7. Has undergone refractive error surgery or intraocular surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Lens A (comfilcon A lens)
1 month
Lens B (lehfilcon A lens)
1 month

Locations

Country Name City State
Canada Eyes on Sheppard Clinic Toronto Ontario
Canada Spadina Optometry Toronto Ontario
United States Coan Eye Care Ocoee Florida
United States Nittany Eye Associate State College Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Coopervision, Inc. CORE

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective Ratings on Lens Handling on Removal Subjective ratings on lens handling on removal will be measured on a scale of 0-10, 0.5 steps (10= Very Easy, 0= Very Difficult) Day 27
See also
  Status Clinical Trial Phase
Completed NCT04532099 - Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses N/A
Completed NCT03319212 - Clinical Characterization of Symptomatic Populations N/A
Withdrawn NCT04525170 - Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Hexafocon A N/A
Completed NCT05483127 - Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses N/A
Completed NCT01741987 - Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome and Post Refractive Surgery Patients N/A
Completed NCT03688672 - Apioc Contact Lens Feasibility N/A
Completed NCT02312323 - One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses N/A
Recruiting NCT04714424 - Comparing Vision Tests in a Virtual Reality Headset to Existing Analogues
Recruiting NCT04632784 - Clinical Trial With Artiflex Presbyopic N/A
Completed NCT04185701 - Comparison of Subjective Refraction Measurement With SiVIEW Software and by an Expert N/A
Completed NCT01706770 - Evaluation of Enfilcon A Soft Contact Lens When Compared to Galyfilcon A Soft Contact Lens N/A
Completed NCT03556579 - The Effects of Contact Lenses With Experimental Dye on Visual Function N/A
Completed NCT04654455 - Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP
Not yet recruiting NCT06295536 - Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children N/A
Completed NCT00691197 - Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear Phase 2/Phase 3
Completed NCT00597467 - Study of Soft Contact Lens Use With 7 Day Extended Wear N/A
Completed NCT04067050 - A Clinical Study of the Comfilcon A Asphere Soft Contact Lens in Users of Digital Devices N/A
Completed NCT04067141 - The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses N/A
Completed NCT02553681 - Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Roflufocon D N/A
Completed NCT00722891 - Ocular Responses to Short and Long-term Lens Wear N/A