Comparison of Two Silicone Hydrogel Toric Contact Lenses
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE
Silicone hydrogel soft contact lenses for astigmatism
Other Names:
Device: Lotrafilcon B toric contact lenses
Silicone hydrogel soft contact lenses for astigmatism
Other Names:
|
| Other: 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. |
Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE
Silicone hydrogel soft contact lenses for astigmatism
Other Names:
Device: Lotrafilcon B toric contact lenses
Silicone hydrogel soft contact lenses for astigmatism
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location) [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alcon Investigative Site | Johns Creek | Georgia | United States | 30097 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Alcon, A Novartis Division, Alcon, A Novartis Division
Study Documents (Full-Text)
More Information
Publications
None provided.- CLC127-C001
Study Results
Participant Flow
| Recruitment Details | Subjects were recruited from one investigative site located in the US. |
|---|---|
| Pre-assignment Detail | This reporting group includes all enrolled subjects (36). |
| Arm/Group Title | AOHG Toric, Then AO Toric | AO Toric, Then AOHG Toric |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Period 1, FIrst 30 Minutes of Wear | ||
| STARTED | 18 | 18 |
| COMPLETED | 18 | 18 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Period 1, FIrst 30 Minutes of Wear | ||
| STARTED | 18 | 18 |
| COMPLETED | 18 | 18 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Overall |
|---|---|
| Arm/Group Description | Lotrafilcon B toric contact lenses with HYDRAGLYDE® and lotrafilcon B toric contact lenses worn during Period 1 and Period 2 in a crossover assignment |
| Overall Participants | 36 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
51.5
(13.9)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
29
80.6%
|
| Male |
7
19.4%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
3
8.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
6
16.7%
|
| White |
27
75%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
Outcome Measures
| Title | Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location) |
|---|---|
| Description | 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. |
| Time Frame | Day 1, 10 minutes after lens insertion, each product |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | AOHG Toric | AO Toric |
|---|---|---|
| Arm/Group Description | Lotrafilcon B toric contact lenses with HYDRAGLYDE® worn in both eyes for approximately 30 minutes during either Period 1 or Period 2, as randomized | Lotrafilcon B toric contact lenses worn in both eyes for approximately 30 minutes in either Period 1 or Period 2, as randomized |
| Measure Participants | 36 | 36 |
| Measure Eyes | 72 | 72 |
| Number [percentage of lenses] |
94.4
|
95.8
|
Adverse Events
| Time Frame | Dispense through study completion, approximately 2 hours | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the protocol. This analysis population includes all subjects/eyes exposed to any study lenses evaluated. | |||
| Arm/Group Title | AOHG Toric | AO Toric | ||
| Arm/Group Description | All subjects exposed to lotrafilcon B toric contact lenses with HYDRAGLYDE® in Period 1 or Period 2, as randomized | All subjects exposed to lotrafilcon B toric contact lenses in Period 1 or Period 2, as randomized | ||
All Cause Mortality |
||||
| AOHG Toric | AO Toric | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/36 (0%) | 0/36 (0%) | ||
Serious Adverse Events |
||||
| AOHG Toric | AO Toric | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/36 (0%) | 0/36 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| AOHG Toric | AO Toric | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/36 (0%) | 0/36 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
| Name/Title | CDMA Project Lead, CDMA Vision Care |
|---|---|
| Organization | Alcon, A Novartis Division |
| Phone | 1-888-451-3937 |
| alcon.medinfo@alcon.com |
- CLC127-C001