Clinical Validation of the Apollo Daily Disposable Soft Contact Lenses
1 other identifier
interventional
35
1 country
1
Brief Summary
The purpose of this study was to confirm the design specifications of a Test lens and validate its clinical performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2021
CompletedFirst Submitted
Initial submission to the registry
August 30, 2021
CompletedFirst Posted
Study publicly available on registry
September 5, 2021
CompletedResults Posted
Study results publicly available
August 12, 2024
CompletedAugust 12, 2024
July 1, 2022
1 month
August 30, 2021
July 8, 2024
August 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Comfort With Lens
Participants rated their overall comfort once after 2 days of wear a 0-100 integer scale, where 0=Cannot be tolerated and 100=Excellent comfort.
2 days
Secondary Outcomes (4)
Overall Vision Quality
2 days
Overall Lens Fit Acceptance
2 days
Overall Lens Handling
2 days
Anterior Ocular Health - Corneal Staining Extent
2 days
Study Arms (2)
Test Lens, then Control Lens
EXPERIMENTALParticipants wore Test Lens for 2 days, and then Control Lens for 2 days
Control Lens, then Test Lens
ACTIVE COMPARATORParticipants wore Control Lens for 2 days, and then Test Lens for 2 days
Interventions
Daily disposable with modified lens design for 2 days
Daily disposable lens for 2 days
Eligibility Criteria
You may qualify if:
- Has had a self-reported oculo-visual examination in the last two years.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is an adapted soft contact lens wearer, having worn contact lenses for a minimum 4 weeks prior to the study
- Has spectacle cylinder ≤1.00D in both eyes.
- Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
- Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye.
- Wears CLs in both eyes (monovision acceptable, but not monofit)
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination
- Is willing to wear the study contact lenses for a minimum 8 hours on at least two consecutive days for each study pair.
You may not qualify if:
- Has never worn contact lenses before.
- Has any systemic disease affecting ocular health.
- Is using any concomitant systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye-related clinical or research study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Indiana University School of Optometry
Bloomington, Indiana, 47405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lee Hall BSc PhD MCOptom, FBCLA
- Organization
- CooperVision Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2021
First Posted
September 5, 2021
Study Start
June 17, 2021
Primary Completion
July 31, 2021
Study Completion
July 31, 2021
Last Updated
August 12, 2024
Results First Posted
August 12, 2024
Record last verified: 2022-07