- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04806802
APIOC Sphere and APIOC Astigmatism
January 17, 2022 updated by: Lentechs, LLC
7 Day Trial of APIOC Sphere and APIOC Astigmatism
Vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the APIOC™ Sphere or the APIOC™ Astigmatism contact lenses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92123
- Complete Family Vision Care
-
-
Florida
-
Orlando, Florida, United States, 32803
- Eola Eyes
-
-
Kentucky
-
Lexington, Kentucky, United States, 40517
- Gaddie Eye Centers
-
-
Ohio
-
Miamisburg, Ohio, United States, 45342
- Miamisburg Vision Care
-
New Albany, Ohio, United States, 43054
- Vision Professionals
-
Powell, Ohio, United States, 43065
- EyeCare Professionals of Powell
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subject must provide written informed consent.
- The subject must appear willing and able to adhere to the instructions set forth in this protocol.
- At least 18 years of age and no more than 35 years of age.
- ≤ 4.00 D (diopters) of corneal astigmatism.
- ≤ 2.50 D of refractive astigmatism.
- Refractive error range +4.00 DS to -6.00 DS (diopters sphere)
- Flat and steep keratometry readings within 40 to 48 D.
- Clear, healthy corneas with no irregular astigmatism.
- Normal, healthy conjunctiva in both eyes.
- Free of active ocular disease. Refractive error is permitted.
- Be a current or former (within the last 12 months) contact lens wearer.
- Best-corrected near and distance visual acuity better than or equal to 20/25.
Exclusion Criteria:
- Irregular corneal astigmatism.
- Presbyopia
- Corneal scarring unless off line-of-site and well healed.
- Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
- Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Use of artificial tears less than 3 drops per week is permitted.
- Systemic disease that would interfere with contact lens wear.
- Currently pregnant or lactating (by self-report).
- History of strabismus or eye movement disorder, including exophoria at near that is 4 D or greater than at far, and a receded near point of convergence break that is 6 cm or greater.
- Active allergies that may inhibit contact lens wear.
- Upper eyelid margin at or above the superior limbus.
- History of ocular or lid surgery.
- Immediate family members or significant others of doctors or staff at the clinical site.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: APIOC Sphere or Astigmatism
Single Vision Spherical or Toric Contact Lens
|
Single Vision Contact Lenses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Acuity
Time Frame: Day 7
|
High and Low Contrast LogMAR, Distance
|
Day 7
|
Subjective Vision Quality
Time Frame: Day 7
|
Visual analogue scale
|
Day 7
|
Comfort
Time Frame: Day 7
|
Visual analogue scale
|
Day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective comfort
Time Frame: Day 7
|
Compared to habitual lenses
|
Day 7
|
Subjective vision
Time Frame: Day 7
|
Compared to habitual lenses
|
Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2021
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
October 31, 2021
Study Registration Dates
First Submitted
March 17, 2021
First Submitted That Met QC Criteria
March 17, 2021
First Posted (Actual)
March 19, 2021
Study Record Updates
Last Update Posted (Actual)
January 19, 2022
Last Update Submitted That Met QC Criteria
January 17, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LEN102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No sharing of data is planned.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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