Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers
Status
Completed
Conditions
Myopia
Treatments
Device: galy A
Device: galy A Plus
Device: seno A
Details and patient eligibility
About
The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.
Enrollment
41 patients
Sex
All
Ages
18 to 55 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Must be at least 18 years of age and no more than 55 years of age.
- Must sign written informed consent.
- Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters.
- Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes.
- Must have visual acuity best correctable to 20/25+3 or better for each eye.
- Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No evidence of lid abnormality or infection; No conjunctival abnormality or infection; No clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); No other active ocular disease.
- The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
Exclusion criteria
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Any previous eye surgery involving the anterior segment.
- Pre-existing ocular disease that would preclude contact lens fitting.
- Abnormal lacrimal secretions.
- Keratoconus or other corneal irregularity.
- Pregnancy, lactating or planning a pregnancy at the time of enrollment.
- Participation in any concurrent clinical trial.
- Subject's habitual contact lens type is toric or multifocal.
- Require any concurrent ocular medication.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
41 participants in 6 patient groups
galy A Plus/ galy A / seno A
Other group
Description:
Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Treatment:
Device: seno A
Device: galy A
Device: galy A Plus
galy A Plus / seno A / galy A
Other group
Description:
Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 3: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Treatment:
Device: seno A
Device: galy A
Device: galy A Plus
galy A / galy A Plus / seno A
Other group
Description:
Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Treatment:
Device: seno A
Device: galy A
Device: galy A Plus
galy A / seno A / galy A Plus
Other group
Description:
Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Treatment:
Device: seno A
Device: galy A
Device: galy A Plus
seno A / galy A / glay A Plus
Other group
Description:
Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Treatment:
Device: seno A
Device: galy A
Device: galy A Plus
seno A / galy A Plus / galy A
Other group
Description:
Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: galy A -subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Treatment:
Device: seno A
Device: galy A
Device: galy A Plus
Trial contacts and locations
2
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems