Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees
Status
Completed
Conditions
Astigmatism
Treatments
Device: omafilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: senofilcon A
Study type
Interventional
Funder types
Other
Industry
Identifiers
Details and patient eligibility
About
The purpose of this study is to determine the relative performance of a new toric soft contact lens against three toric contact lens currently available in market, specifically with orientation and visual acuity when head is tilted at 90 degrees.
Full description
Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, ~2 hour duration.
Enrollment
14 patients
Sex
All
Ages
18 to 50 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- be at least 18 and less than or equal to 50 years of age
- be able and willing to adhere to the instructions set forth in the protocol.
- have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D
- Sign the STATEMENT OF INFORMED CONSENT.
- Have normal, healthy eyes
Exclusion criteria
- The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear.
- Pre-existing ocular disease precluding contact lens fitting.
- Insufficient lacrimal secretions
- Aphakia, keratoconus or a highly irregular cornea
- Previous eye surgery involving the anterior segment
- Current pregnancy or lactation (to the best of the subject's knowledge).
- Use of concurrent ocular medication
- Active participation in another clinical study at any time during this study.-
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Single Blind
14 participants in 12 patient groups
Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A
Active Comparator group
Description:
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. Period 1: lotrafilcon B /period 2: senofilcon A / period 3: balafilcon A / period 4: omafilcon A
Treatment:
Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A
Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A
Active Comparator group
Description:
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: omafilcon A / period 3: senofilcon A / period 4: balafilcon A
Treatment:
Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A
Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A
Active Comparator group
Description:
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: balafilcon A / period 3: senofilcon A / period 4: omafilcon A
Treatment:
Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A
Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A
Active Comparator group
Description:
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: balafilcon A
Treatment:
Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A
Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B
Active Comparator group
Description:
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: omafilcon A / period 3: balafilcon A / period 4: lotrafilcon B
Treatment:
Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A
Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A
Active Comparator group
Description:
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: balafilcon A / period 3: lotrafilcon B / period 4: omafilcon A
Treatment:
Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A
Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A
Active Comparator group
Description:
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: omafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: balafilcon A
Treatment:
Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A
Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A
Active Comparator group
Description:
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: omafilcon A
Treatment:
Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A
Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A
Active Comparator group
Description:
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: senofilcon A
Treatment:
Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A
Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A
Active Comparator group
Description:
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: lotrafilcon B / period 4: omafilcon A
Treatment:
Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A
Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B
Active Comparator group
Description:
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: omafilcon A / period 4: lotrafilcon B
Treatment:
Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A
Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A
Active Comparator group
Description:
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: omafilcon A / period 3: lotrafilcon B / period 4: senofilcon A
Treatment:
Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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