Axis Orientation Comparison of Two Silicone Hydrogel Toric Contact Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)
Study Overview
Brief Summary
The purpose of this research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Successful wear of soft contact lenses for vision correction in both eyes during the past 3 months for a minimum of 3 days per week and 8 hours per day
- •Astigmatism
- •Requires contact lenses
- •Best corrected visual acuity of 20/25 or better in each eye
- •Other protocol-specified inclusion criteria may apply
Exclusion Criteria
- •Any eye condition that contraindicates contact lens wear, as determined by the Investigator
- •Any eye surgery that contraindicates contact lens wear, as determined by the Investigator
- •Other protocol-specified exclusion criteria may apply
Arms & Interventions
AOHG toric, then AO toric
Lotrafilcon B toric contact lenses with HYDRAGLYDE, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.
Intervention: Lotrafilcon B toric contact lenses with HYDRAGLYDE (Device)
AOHG toric, then AO toric
Lotrafilcon B toric contact lenses with HYDRAGLYDE, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.
Intervention: Lotrafilcon B toric contact lenses (Device)
AO toric, then AOHG toric
Lotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.
Intervention: Lotrafilcon B toric contact lenses with HYDRAGLYDE (Device)
AO toric, then AOHG toric
Lotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.
Intervention: Lotrafilcon B toric contact lenses (Device)
Outcomes
Primary Outcomes
Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)
Time Frame: Day 1, 10 minutes after lens insertion, each product
Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint.
Secondary Outcomes
No secondary outcomes reported