Clinical trial NCT06046209: Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens
Official title: Comparing Clariti Elite Versus Proclear 1 Day
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Refractive Errors
Eye Diseases
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
Collaborators: name: Centre for Ocular Research & Education, Canada
First posted: 2023-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.

Detailed description: This was a non-dispensing, randomized, double-masked, crossover study. Participants wore 2 different contact lenses bilaterally over 4 study visits, all conducted on the same day. Estimated duration of involvement for each participant was 4 hours.

Eligibility criteria: Inclusion Criteria:

1. Were 17 to 40 years of age and have full legal capacity to volunteer;
2. Had read and signed an information consent letter;
3. Were willing and able to follow instructions and maintain the appointment schedule;
4. Were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye
5. Were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction;
6. Had an astigmatism of ≤ 0.75DC in subjective refraction;
7. Could be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit.
8. Demonstrated an acceptable fit with the study lenses.

Exclusion Criteria:

1. Had taken part in another clinical research study within the last 14 days;
2. Were currently habitual wearers of toric, multifocal or monovision lenses.
3. Had worn any rigid contact lenses in the past 6 months
4. Were an extended lens wearer (i.e., sleeping with their lenses)
5. Had a difference of ≥1.5 D in best vision sphere subjective refraction between eyes;
6. Had amblyopia and/or distance strabismus/binocular vision problem;
7. Had any known active ocular disease, allergies and/or infection;
8. Had a systemic condition that in the opinion of the investigator may affect a study outcome variable;
9. Were using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
10. Had a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
11. Had undergone refractive error surgery or intraocular surgery;
12. Were a member of CORE directly involved in the study.

Primary outcomes:
measure: Lens Handling at Insertion
timeFrame: Immediately after lens application
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo School of Optometry & Vision Science
state: Ontario
Study officials:
affiliation: Centre for Ocular Research and Education (CORE)
name: Lyndon Jones, PhD FCOptom
role: PRINCIPAL_INVESTIGATOR
References: