Comparison of Two Silicone Hydrogel Toric Contact Lenses

Study Overview
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Brief Summary
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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.

Official Title
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Axis Orientation Comparison of Two Silicone Hydrogel Toric Contact Lenses

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE
* Device: Lotrafilcon B toric contact lenses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AOHG toric, then AO toric<br>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. | Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE<br>* Silicone hydrogel soft contact lenses for astigmatism<br>* Other names: AOHG for Astigmatism;Device: Lotrafilcon B toric contact lenses<br>* Silicone hydrogel soft contact lenses for astigmatism<br>* Other names: AO for Astigmatism;|
| Other: AO toric, then AOHG toric<br>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. | Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE<br>* Silicone hydrogel soft contact lenses for astigmatism<br>* Other names: AOHG for Astigmatism;Device: Lotrafilcon B toric contact lenses<br>* Silicone hydrogel soft contact lenses for astigmatism<br>* Other names: AO for Astigmatism;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location) | 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. | Day 1, 10 minutes after lens insertion, each product | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Astigmatism, Axis orientation