Product Performance of a Toric Contact Lens
Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00658996
Collaborator
(none)
220
1
2
2
109.8
Study Details
Study Description
Brief Summary
Product performance of a Bausch & Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
220 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Study to Evaluate the Product Performance of a Prism-Ballasted Toric Contact Lens When Worn by Currently Adapted Soft Contact Lens Wearers.
Study Start Date
:
Apr 1, 2008
Actual Primary Completion Date
:
Jun 1, 2008
Actual Study Completion Date
:
Jun 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SofLens DD Toric Bausch & Lomb SofLens Daily Disposable Toric Contact Lens |
Device: SofLens DD Toric
daily disposable wear contact lens for 2 weeks
|
| Active Comparator: Ciba Vision Toric Lens Ciba Vision Focus Dailies Toric Contact Lens |
Device: Ciba Vision Focus Dailies Toric Contact Lens
daily disposable wear contact lens for 2 weeks
|
Outcome Measures
Primary Outcome Measures
- Symptoms and Complaints [Over-all follow-up visits for 2 week period]
1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.
- Contact Lens High Contrast Visual Acuity [Over-all follow-up visits, 2 weeks]
VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA.
Secondary Outcome Measures
- Slit Lamp Findings [Over-all follow-up visits, 2 weeks]
Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject is an adapted soft contact lens wearer with astigmatism of 0.50 Diopter or greater
-
Visual acuity (VA) correctable to 0.3 logMar or better (driving vision)
-
Clear central cornea
Exclusion Criteria:
-
Systemic disease affecting ocular health
-
Using systemic or topical medications
-
Wears monovision or multifocal contact lenses
-
Any grade 2 or greater slit lamp findings
-
Adapted wearer of Ciba Focus Dailies Toric lens upon study entry
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laser Focus Sdn Bhd, Vision Correction Centre | Johor Bahru | Malaysia | 80400 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Gerard Cairns, PhD,MCOptom, Bausch & Lomb Incorporated
- Principal Investigator: Benny Chian, MCOptom,DO, Laser Focus Sdn Bhd, Vision Correction Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00658996
Other Study ID Numbers:
- 559
First Posted:
Apr 16, 2008
Last Update Posted:
Dec 12, 2011
Last Verified:
Dec 1, 2011
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This 4-week study was conducted at 12 sites in Asia. First participant enrolled 4/16/08, last participant visit was 6/20/08 |
|---|---|
| Pre-assignment Detail | 220 participants were enrolled in the study, 4 participants were ineligible at screening visit, 216 Subjects started the first intervention. 211 participants started the second intervention. 209 participants completed the study. |
| Arm/Group Title | SofLens DD Toric First, Then Focus Dailies Toric | Focus Dailies Toric First, Then SofLens DD Toric |
|---|---|---|
| Arm/Group Description | Bausch & Lomb SofLens Daily Disposable Toric Contact Lens first then crossover to Ciba Vision Focus Dailies Toric Lens | Ciba Vision Focus Dailies Toric Lens first, then crossover to Bausch & Lomb SofLens Daily Disposable Toric Contact Lens |
| Period Title: First Intervention | ||
| STARTED | 109 | 107 |
| COMPLETED | 108 | 106 |
| NOT COMPLETED | 1 | 1 |
| Period Title: First Intervention | ||
| STARTED | 108 | 106 |
| COMPLETED | 106 | 105 |
| NOT COMPLETED | 2 | 1 |
| Period Title: First Intervention | ||
| STARTED | 106 | 105 |
| COMPLETED | 105 | 104 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Entire Study Population |
|---|---|
| Arm/Group Description | Population enrolled at start of study |
| Overall Participants | 216 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
28.7
(7.19)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
150
69.4%
|
| Male |
66
30.6%
|
| Race/Ethnicity, Customized (participants) [Number] | |
| Asian |
216
100%
|
| White |
0
0%
|
| Black |
0
0%
|
| Other |
0
0%
|
Outcome Measures
| Title | Symptoms and Complaints |
|---|---|
| Description | 1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable. |
| Time Frame | Over-all follow-up visits for 2 week period |
Outcome Measure Data
| Analysis Population Description |
|---|
| All eligible, dispensed eyes, Overall follow-up visits. |
| Arm/Group Title | SofLens DD Toric | Focus Dailies Toric |
|---|---|---|
| Arm/Group Description | Bausch & Lomb SofLens Daily Disposable Toric Contact Lens | Ciba Vision Focus Dailies Toric contact lenses |
| Measure Participants | 213 | 210 |
| Measure eyes | 426 | 420 |
| Comfort |
79.3
(17.1)
|
77.7
(17.6)
|
| End of Day Comfort |
73.5
(19.6)
|
71.5
(19.9)
|
| Lens Awareness |
78.8
(17.9)
|
75.6
(20.4)
|
| Lens Cleanliness |
87.5
(12.7)
|
86.5
(13.0)
|
| Irritation |
83.0
(15.6)
|
79.3
(19.6)
|
| Itching |
86.4
(14.9)
|
83.9
(17.2)
|
| Dryness |
77.4
(18.0)
|
73.7
(20.3)
|
| Redness |
86.3
(14.9)
|
81.5
(19.5)
|
| Vision |
77.1
(19.1)
|
84.3
(14.6)
|
| Lens Handling |
87.4
(13.0)
|
76.1
(21.2)
|
| Overall Impression |
78.7
(16.2)
|
75.9
(17.5)
|
| Title | Slit Lamp Findings |
|---|---|
| Description | Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates |
| Time Frame | Over-all follow-up visits, 2 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All dispensed eyes, over all follow-up visits |
| Arm/Group Title | SofLens DD Toric | Focus Dailies Toric |
|---|---|---|
| Arm/Group Description | Bausch & Lomb SofLens Daily Disposable Toric Contact Lens | Ciba Vision Focus Dailies Toric contact lenses |
| Measure Participants | 215 | 215 |
| Measure eyes | 430 | 430 |
| Slit Lamp Findings > Grade 2 |
0
|
2
|
| Slit Lamp Findings </= Grade 2 |
430
|
428
|
| Title | Contact Lens High Contrast Visual Acuity |
|---|---|
| Description | VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA. |
| Time Frame | Over-all follow-up visits, 2 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All eligible, dispensed eyes |
| Arm/Group Title | SofLens DD Toric | Focus Dailies Toric |
|---|---|---|
| Arm/Group Description | Bausch & Lomb SofLens Daily Disposable Toric Contact Lens | Ciba Vision Focus Dailies Toric contact lenses |
| Measure Participants | 213 | 210 |
| Measure eyes | 426 | 420 |
| Mean (Standard Deviation) [LogMAR] |
-0.007
(0.0669)
|
-0.014
(0.0696)
|
Adverse Events
| Time Frame | One month | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | SofLens DD Toric | Ciba Vision Toric Lens | ||
| Arm/Group Description | Bausch & Lomb SofLens Daily Disposable Toric Contact Lens | Ciba Vision Focus Dailies Toric Lens | ||
All Cause Mortality |
||||
| SofLens DD Toric | Ciba Vision Toric Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| SofLens DD Toric | Ciba Vision Toric Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/215 (0%) | 0/216 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| SofLens DD Toric | Ciba Vision Toric Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/215 (0%) | 0/216 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Gerard Cairns, PhD, MCOptom |
|---|---|
| Organization | Bausch & Lomb Incorporated |
| Phone | (585) 338-5170 |
| gerard.cairns@bausch.com |
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00658996
Other Study ID Numbers:
- 559
First Posted:
Apr 16, 2008
Last Update Posted:
Dec 12, 2011
Last Verified:
Dec 1, 2011