A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses

Presbyopia Clinical Trial

Official title:

A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719353
• Other study ID #: CV-16-02
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: August 2016

Study information

• Verified date: July 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.

Description:

This study is a 13-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

• Has had a self-reported oculo-visual examination in the last two years

• Is 50 years of age or greater and has full legal capacity to volunteer

• Is able to read and understand the informed consent

• Is willing and able to follow instructions and maintain the appointment schedule

• Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)

• Near Add Power requirement of +2.25D or greater

• Has spectacle cylinder 0.75 D in both eyes

• Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia = 2.00D)

• Has monocular best-corrected distance visual acuity of 20/30 or better in each eye

• Has clear corneas and no active ocular disease

• Has not worn gas permeable contact lenses for 1 month prior to the study

Exclusion Criteria:

A person will be excluded from the study if he/she:

• Has never worn contact lenses before

• Has any systemic disease affecting ocular health

• Is using any systemic or topical medications that will affect ocular health

• Has any ocular pathology or abnormality that would affect the wearing of contact lenses

• Is aphakic (i.e. missing their natural lens inside their eye)

• Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of =2.00 D

• Has undergone corneal refractive surgery

• Is participating in any other type of eye related clinical or research study.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• comfilcon A Extended Range test lens
contact lens
• comfilcon A control lens
contact lens

Locations

Country	Name	City	State
United States	CORL, Indiana University	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR.	4 days
Primary	Visual Performance	Subjective assessment of visual performance for test and control lens is assessed on a scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time).	4 days
Secondary	Subjective Ratings for Comfort	Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).	Baseline
Secondary	Subjective Ratings for Comfort	Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).	4 days
Secondary	Subjective Ratings for Dryness	Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).	Baseline
Secondary	Subjective Ratings for Dryness	Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).	4 days
Secondary	Lens Handling	Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle).	4 Days
Secondary	Average Daily Wearing Time	Average daily wearing time for test and control lens is assessed in hours.	4 days
Secondary	Lens Fit	Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 grading system in 0.25 steps where 0 represented very poor fit.	4 days
Secondary	Bulbar Hyperemia	Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.	4 days
Secondary	Limbal Hyperemia	Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.	4 days
Secondary	Subjective Satisfaction	Subjective satisfaction for test and control lens was assessed on a scale 0-100, 0=extremely dissatisfied, 100=very satisfied)	4 days
Secondary	Subjective Preference for Near Vision	Subjective preference for near vision for test and control contact lenses. comfort, vision, handling, satisfaction.	4 days
Secondary	Subjective Preference for Distance Vision	Subjective preference for distance vision for test and control contact lenses.	4 days
Secondary	Subjective Preference for Intermediate Vision	Subjective preference for intermediate vision for test and control contact lenses.	4 days
Secondary	Subjective Preference for Overall Vision	Subjective preference for overall vision for test and control contact lenses.	4 days
Secondary	Subjective Preference for Comfort	Subjective preference for comfort for test and control contact lenses.	4 days
Secondary	Subjective Overall Lens Preference	Subjective overall lens preference for test and control contact lenses.	4 days