Clinical trial NCT03688672: Apioc Contact Lens Feasibility
Official title: Evaluation of the Feasibility of Fitting of Apioc Contact Lenses in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Myopia
Hyperopia
Astigmatism
Presbyopia
Keywords: contact lens
soft contact lens
feasibility
Lead sponsor: Lentechs, LLC
Sponsor class: INDUSTRY
First posted: 2018-09-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This clinical trial will document the feasibility of the Apioc lens design by assessing which lens shape parameters yield successful on-eye-fit and movement of the Apioc contact lens design and evaluate the subjectively-reported comfort of the Apioc contact lens design.

Detailed description: This is a one-site, non-dispensing clinical trial using the Apioc contact lens design. This soft contact lens study will determine the feasibility of this design by determining which parameters of the shape of the Apioc Contact Lens design will yield a successful fit across subjects. We will also determine the percentage of subjects who can be successfully fitted with the Apioc Contact Lens Design. Because the feasibility of the lens design may be dependent upon age, a total of 50 subjects (10 subjects each across 5 decades of life) will complete the study. The data will be collected in a single visit for most subjects. A few subjects may be asked to return for a second visit if additional contact lens parameters need to be ordered to achieve a successful fit. The key assessments for this study will be demonstration of feasibility of fit, documentation of movement in all gazes, including translation, and subjective reports of comfort. Subjects will only wear contact lenses while in the office.

Eligibility criteria: Inclusion Criteria:

1. Thirty subjects will be at least 40 years of age and no more than 60 years of age. Ten subjects will be at least 18 years of age and no more than 29 years of age. Ten subjects will be at least 30 years of age and no more than 39 years of age.
2. The subject must have ≤ 1.50 D of corneal astigmatism.
3. The subject should have clear, healthy corneas.
4. The subject should have a normal, healthy conjunctiva in both eyes.
5. The subject should be free of active ocular disease. Refractive error and presbyopia are permitted.
6. The subject must provide written informed consent.
7. The subject must appear willing and able to adhere to the instructions set forth in this protocol.

Exclusion Criteria:

1. No irregular corneal astigmatism is permitted.
2. No pterygia or corneal scarring that would interfere with contact lens wear.
3. No pinguecula or other conjunctival thickness abnormalities are permitted that would interfere with contact lens wear.
4. The subject should not be using any ocular pharmaceutical treatments, including artificial tears in the two weeks prior to the examination.

Primary outcomes:
measure: Vertical Movement of Contact Lens in Downgaze
timeFrame: After 15 minutes of on-eye settling
Secondary outcomes:
measure: Movement of contact lens with blink
timeFrame: After 15 minutes of on-eye settling
measure: Visual Acuity
timeFrame: After 15 minutes of on-eye settling
measure: Comfort questionnaire
timeFrame: After 15 minutes of on-eye settling
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Heidi Wagner, OD, MS
role: PRINCIPAL_INVESTIGATOR
References: