Effect of FID 114675A on Lens Wettability
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FID 114675A Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to one eye, with contact lens removed directly from the blister pack assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours. |
Device: FID 114675A multi-purpose disinfecting solution (MPDS)
Investigational multi-purpose disinfecting solution intended for use as a cleaning, reconditioning, rinsing, disinfecting, and storage solution for silicone hydrogel and soft contact lenses.
Device: Soft contact lens
Soft hydrogel or silicone hydrogel contact lens matching subject's pre-study lens, including parameters, worn 16 hours on day of dispense.
Other Names:
|
| Active Comparator: Blister Pack Contact lens removed directly from the blister pack randomly assigned to one eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours. |
Device: Soft contact lens
Soft hydrogel or silicone hydrogel contact lens matching subject's pre-study lens, including parameters, worn 16 hours on day of dispense.
Other Names:
Device: Blister pack solution
Commercially approved storage solution as found in the contact lens blister pack.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Lens Wettability [16 hours]
As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years or age or older with normal eyes, other than correction for refractive error.
-
At least 5 days successful daily wear (minimum 8 hours per day) of PureVision®, Acuvue® Oasys™, or Acuvue® 2 contact lenses prior to Visit 1
-
Vision correctable to 20/30 (Snellen) or better in each eye at distance with lenses at Visit 1 (Day 0 - Baseline).
-
Grade 0 or Grade 1 wettability in both eyes after at least 15 minutes of lens wear at Visit 1 (Day 0 - Baseline).
-
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
-
Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of the study.
-
Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
-
Use of products other than a multi-purpose solution or hydrogen peroxide solution, including daily and enzyme cleaners and saline rinses, for lens care at least 7 days prior to Visit 1 (Day 0 - Baseline).
-
Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. Use of lens rewetting drops is acceptable.
-
History or current ocular infections or ocular inflammatory events.
-
Ocular surgery within the past year.
-
Participation in any investigational study within the past 30 days.
-
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | United States | 76314 |
Sponsors and Collaborators
- Alcon Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C-10-024
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | FID 114675A | Blister Pack |
|---|---|---|
| Arm/Group Description | Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear. | Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear. |
| Period Title: Overall Study | ||
| STARTED | 34 | 32 |
| COMPLETED | 34 | 32 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | FID 114675A | Blister Pack | Total |
|---|---|---|---|
| Arm/Group Description | Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear. | Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear. | Total of all reporting groups |
| Overall Participants | 34 | 32 | 66 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
36.6
(10.76)
|
37.3
(12.34)
|
36.9
(11.47)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
25
73.5%
|
22
68.8%
|
47
71.2%
|
| Male |
9
26.5%
|
10
31.3%
|
19
28.8%
|
Outcome Measures
| Title | Lens Wettability |
|---|---|
| Description | As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated. |
| Time Frame | 16 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat. All subject-eyes that received contact lenses pre-soaked per treatment regimen and completed Visit 2 (Day 1 - Exit at 16 hours) were included in the ITT data set. |
| Arm/Group Title | FID 114675A | Blister Pack |
|---|---|---|
| Arm/Group Description | Contact lens soaked overnight in an investigational multi-purpose disinfecting solution and inserted on day of dispense for 16 hours of wear. | Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear. |
| Measure Participants | 66 | 66 |
| Number (95% Confidence Interval) [percentage of lenses] |
95.5
|
97.0
|
Adverse Events
| Time Frame | Adverse events were collected for the duration of the study: October 11, 2010 through February 2, 2011. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All subjects who received contact lenses pre-soaked per treatment regimen were evaluable for the safety analysis. | |||
| Arm/Group Title | FID 114675A | Blister Pack | ||
| Arm/Group Description | Contact lens soaked overnight in an investigational multi-purpose disinfecting solution and inserted on day of dispense for 16 hours of wear. | Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear. | ||
All Cause Mortality |
||||
| FID 114675A | Blister Pack | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| FID 114675A | Blister Pack | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/66 (0%) | 0/66 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| FID 114675A | Blister Pack | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/66 (0%) | 0/66 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Alcon reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
| Name/Title | Director of Alcon Clinical |
|---|---|
| Organization | Alcon Research, Ltd. |
| Phone | 1-888-451-3937 |
| medinfo@alconlabs.com |
- C-10-024