Somofilcon A 1-Day Multifocal Study - Real World Subjective Acceptance Study

Presbyopia Clinical Trial

Official title:

Clariti 1-Day Multifocal Study - 'Real World' Subjective Acceptance Study (HARP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519919
• Other study ID #: EX-MKTG-81
• Status: Completed
• Phase: N/A
• Start date: August 21, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: December 2019
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to evaluate the performance of somofilcon A 1 day multifocal when worn on a daily disposable wear modality over a period of up to 3 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 15, 2019
• Est. primary completion date: September 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Is at least 17 years of age and has full legal capacity to volunteer;

• Has read and signed an information consent letter;

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

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

• Currently wears multifocal soft contact lenses, and have worn multifocal contact lenses for at least one month;

• Presently wears lenses for minimum wear 4 days/week and 10 hours/day

• Participant has an anticipated ability to wear test lenses for minimum 5 days/week and 10 hours/day.

• Can be fit with the available test contact lens power range to achieve satisfactory vision i.e. 0.18 logMar (20/30) binocular distance acuity with the test lenses.

• Current refraction indicates a reading addition of +1.50 or higher

• Uses a digital device (computer/laptop/tablet etc.) for at least 5hrs/day

• Spends 10 hrs or more indoors at least 5 days/week

• Possesses a smartphone and is willing to download the MetricWire app to receive

Exclusion Criteria:

• Is presently wearing Clariti 1 day multifocal lenses

• Has astigmatism greater than -0.75 DCyl as determined with subjective refraction

• Is participating in any concurrent clinical or research study;

• Has any known active* ocular disease and/or infection;

• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

• Has known sensitivity to fluorescein dye or products to be used in the study;

• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);

• Is aphakic;

• Has undergone refractive error surgery;

• Is an employee of the Centre for Contact Lens Research

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• somofilcon A multifocal lens
contact lens

Locations

Country	Name	City	State
Canada	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vision Clarity During the Day - Distance Vision	Subjective expectation -Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below: Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3	Baseline
Primary	Vision Clarity During the Day - Distance Vision	Subjective expectation - Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below: Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3	3 weeks
Secondary	Number of Participants With Lens Centration	Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm))	Baseline
Secondary	Number of Participants With Lens Centration	Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm))	3 weeks
Secondary	Visual Acuity	Distance visual acuity (logMAR)	Baseline
Secondary	Visual Acuity	Distance visual acuity (logMAR)	3 weeks
Secondary	Post-blink Lens Movement	Movement of lens on eye after blink was graded on a 5-point Likert scale (0-4, 1 steps) as follows: 0 - insufficient, 1 - minimal but acceptable, 2 - optimal, 3 - moderate but acceptable, and 4 - excessive unacceptable movement.	Baseline
Secondary	Post-blink Lens Movement	Movement of lens on eye after blink was graded on a 5-point scale (0-4, 1 steps) as follows: 0 - insufficient, 1 - minimal but acceptable, 2 - optimal, 3 - moderate but acceptable , and 4 - excessive unacceptable.	3 weeks
Secondary	Corneal Staining	Corneal staining will be assessed for extent (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior and Central.	Baseline
Secondary	Corneal Staining	Corneal staining will be assessed for extent (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior and Central.	3 weeks
Secondary	Conjunctival Staining	Conjunctival staining will be assessed using CORE integer scale (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior.	Baseline
Secondary	Conjunctival Staining	Conjunctival staining will be assessed using CORE integer scale (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentationfor following regions: Temporal, Superior, Nasal, Inferior.	3 weeks
Secondary	Bulbar Hyperemia	Grading hyperemia of bulbar conjunctiva on a scale ranged from 0-4 and in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.	Baseline
Secondary	Bulbar Hyperemia	Grading hyperemia of bulbar conjunctiva on a scale ranged from 0-4 and in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.	3 weeks
Secondary	Subjective Vision Satisfaction - Driving at Night	Subjective satisfaction of distance vision while driving at night responses for habitual lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation)	Baseline
Secondary	Subjective Vision Satisfaction - Driving at Night	Subjective satisfaction of distance vision while driving at night responses for somofilcon A multifocal lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation)	3 weeks
Secondary	Subjective Vision Satisfaction - Long Intermediate Vision	Subjective satisfaction of long intermediate vision while using desktop computer for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)	Baseline
Secondary	Subjective Vision Satisfaction - Long Intermediate Vision	Subjective satisfaction of long intermediate vision while using desktop computer for somofilcon A multifocal lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)	3 weeks
Secondary	Subjective Vision Satisfaction - Short Intermediate Tasks	Subjective satisfaction of short/intermediate vision while using laptop/tablet for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)	Baseline
Secondary	Subjective Vision Satisfaction - Short Intermediate Tasks	Subjective satisfaction of short/intermediate vision while using laptop/tablet for somofilcon A multifocal lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)	3 weeks
Secondary	Subjective Vision Satisfaction - Near Vision	Subjective satisfaction of near vision while reading on cell phone and hand-held materials for habitual lens (1 = fell short of expectation, 2 = met expectation, 3 = exceed expectation)	Baseline
Secondary	Subjective Vision Satisfaction - Near Vision	Subjective satisfaction of near vision while reading on cell phone and hand-held materials for somofilcon A multifocal lens (1 = fell short of expectation, 2 = met expectation, 3 = exceed expectation)	3 weeks
Secondary	Ease of Insertion	Subjective rating how easy lens was inserted on eye for habitual lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)	Baseline
Secondary	Ease of Insertion	Subjective rating how easy lens was inserted on eye for somofilcon A multifocal lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)	3 weeks
Secondary	Ease of Removal	Subjective rating for habitual lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)	Baseline
Secondary	Ease of Removal	Subjective rating for somofilcon A multifocal lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)	3 weeks
Secondary	Overall Satisfaction With Speed of Changing Focus	Subjective rating for speed and ability to change focus between distances for habitual lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)	Baseline
Secondary	Overall Satisfaction With Speed of Changing Focus	Subjective rating for speed and ability to change focus between distances for somofilcon A multifocal lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)	3 weeks
Secondary	Overall Satisfaction Preference Between Study and Habitual Contact Lenses	Subjective satisfaction preference of contact lens between study and habitual contact lenses(Fell short of expectations, Met my expectation, Exceeded my expectation)	Baseline
Secondary	Overall Satisfaction Preference Between Study and Habitual Contact Lenses	Subjective satisfaction preference between study and habitual contact lenses (Fell short of expectations, Met ,my expectations, Exceeded my expectations))	3 weeks
Secondary	Overall Comfort	Subjective rating of comfort for habitual lens and somofilcon A multifocal lens at 3 weeks (Prefer my own strongly, Prefer my own slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly)	3 weeks
Secondary	Overall Preference Between Study and Habitual Contact Lenses for Lifestyle	Preference of contact lens for the whole range of tasks (Prefer strongly, Prefer slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly)	3 weeks