Clinical trial NCT04005885: A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Official title: A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2019-07-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.

Detailed description: This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were randomized to wear each daily disposable lens type for one week.

Eligibility criteria: Inclusion Criteria:

* Subjects will only be eligible for the study if:
* They are between 18 and 40 years of age (inclusive).
* They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They are an existing soft reusable spherical contact lens wearer in both eyes.
* They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction.
* They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction
* They own a wearable pair of spectacles and wear them on the day of the initial visit.
* They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles.
* They agree not to participate in other clinical research for the duration of the study.

Exclusion Criteria:

* 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.
* 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 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 other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Primary outcomes:
measure: Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use
timeFrame: 4 weeks
measure: Subjective Scores of Comfort on Insertion
timeFrame: 1 week
Secondary outcomes:
measure: Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use
timeFrame: 4 weeks
measure: Subjective Scores on Overall Comfort
timeFrame: 1 week
measure: Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use
timeFrame: 4 weeks
measure: Subjective Scores on Comfort Before Removal
timeFrame: 1 week
measure: Number of Participants With Horizontal Lens Centration Grade
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear
timeFrame: 4 weeks
measure: Number of Participants With Horizontal Lens Centration Grade
timeFrame: 1 week
measure: Number of Participants With Vertical Lens Centration Grade
timeFrame: Baseline (After 5 minutes of lens dispense)
measure: Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear
timeFrame: 4 weeks
measure: Number of Participants With Vertical Lens Centration Grade
timeFrame: 1 week
measure: Number of Participants With Lens Corneal Coverage Grade
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear
timeFrame: 4 weeks
measure: Number of Participants With Lens Corneal Coverage Grade
timeFrame: 1 week
measure: Number of Participants With Post-Blink Movement Grade
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear
timeFrame: 4 weeks
measure: Number of Participants With Post-Blink Movement Grade
timeFrame: 1 week
measure: Investigator Lens Fit Acceptance
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use
timeFrame: 4 weeks
measure: Investigator Lens Fit Acceptance
timeFrame: 1 week
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research - The University of Manchester
Study officials:
affiliation: Eurolens Research
name: Carole Maldonado-Codina, PhD, MCOptom, FAAO, FBCLA
role: PRINCIPAL_INVESTIGATOR
References: