Evaluation of the Feasibility a New Silicone Hydrogel Contact Lens
Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01309906
Collaborator
(none)
66
1
2
2
32.4
Study Details
Study Description
Brief Summary
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of an investigational contact lens.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
66 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Study Start Date
:
Dec 1, 2010
Actual Primary Completion Date
:
Jan 1, 2011
Actual Study Completion Date
:
Feb 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Investigational lens Bausch & Lomb investigational silicone hydrogel lens |
Device: Investigational lens
Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week.
|
| Active Comparator: Air Optix Aqua lens Ciba Vision Air Optix Aqua contact lens |
Device: Air Optix Aqua lens
Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week.
|
Outcome Measures
Primary Outcome Measures
- Visual Acuity [At 1 week follow up]
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Secondary Outcome Measures
- Percentage of Eyes With > Grade 2 Slit Lamp Findings [At 1 week follow up]
Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities.
- Symptoms and Complaints [At 1 week follow up]
At 1-Week Follow-up, subjects were asked to rate 16 common symptoms/complaints on a scale of 0 to 100, with 100 being the most favorable score.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
-
Be myopic and require lens correction in each eye.
-
Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Exclusion Criteria:
-
Any systemic disease affecting ocular health.
-
Using any systemic or topical medications that will affect ocular physiology or lens performance.
-
An active ocular disease, any corneal infiltrative response or are using any ocular medications.
-
Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
-
Allergic to any component in the study care products.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bausch & Lomb Incorporated | Rochester | New York | United States | 14609 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Principal Investigator: Tara Vaz, OD, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01309906
Other Study ID Numbers:
- 688E
First Posted:
Mar 7, 2011
Last Update Posted:
Oct 22, 2020
Last Verified:
Sep 1, 2020
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 66 participants (132 eyes) were enrolled in the study. One-half were randomized to receive the investigational lens, and the other half were randomized to receive the control lens. After one week of wearing the first lens type, the subjects returned for an exam and crossed over to the second lens type for one week. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Investigational Lens Then Air Optix Aqua Lens | Air Optix Aqua Lens Then Investigational Lens |
|---|---|---|
| Arm/Group Description | Bausch & Lomb investigational silicone hydrogel lens Investigational lens: Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week. Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week. | Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week. Bausch & Lomb investigational silicone hydrogel lens Investigational lens: Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week. |
| Period Title: Overall Study | ||
| STARTED | 33 | 33 |
| COMPLETED | 32 | 32 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Overall |
|---|---|
| Arm/Group Description | All participants received both treatment groups. |
| Overall Participants | 66 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
31.1
(9.0)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
44
66.7%
|
| Male |
22
33.3%
|
Outcome Measures
| Title | Visual Acuity |
|---|---|
| Description | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). |
| Time Frame | At 1 week follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 65 subjects (130 eyes) in each group for this outcome measure. |
| Arm/Group Title | Investigational Lens | Air Optix Aqua Lens |
|---|---|---|
| Arm/Group Description | Bausch & Lomb investigational silicone hydrogel lens Investigational lens: Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week. | Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week. |
| Measure Participants | 65 | 65 |
| Measure eyes | 130 | 130 |
| Least Squares Mean (Standard Deviation) [logMAR] |
-0.038
(0.088)
|
-0.040
(0.088)
|
| Title | Percentage of Eyes With > Grade 2 Slit Lamp Findings |
|---|---|
| Description | Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities. |
| Time Frame | At 1 week follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 65 subjects (130 eyes) in each group for this outcome measure. |
| Arm/Group Title | Investigational Lens | Air Optix Aqua Lens |
|---|---|---|
| Arm/Group Description | Bausch & Lomb investigational silicone hydrogel lens Investigational lens: Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week. | Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week. |
| Measure Participants | 65 | 65 |
| Measure eyes | 130 | 130 |
| Count of Units [eyes] |
0
|
0
|
| Title | Symptoms and Complaints |
|---|---|
| Description | At 1-Week Follow-up, subjects were asked to rate 16 common symptoms/complaints on a scale of 0 to 100, with 100 being the most favorable score. |
| Time Frame | At 1 week follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 65 subjects (130 eyes) in each group for this outcome measure. |
| Arm/Group Title | Investigational Lens | Air Optix Aqua Lens |
|---|---|---|
| Arm/Group Description | Bausch & Lomb investigational silicone hydrogel lens Investigational lens: Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week. | Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week. |
| Measure Participants | 65 | 65 |
| Measure eyes | 130 | 130 |
| Burning/stinging upon insertion |
89.7
(16.7)
|
90.5
(16.7)
|
| Comfort upon insertion |
86.6
(18.9)
|
86.9
(18.9)
|
| Overall comfort |
85.7
(18.4)
|
87.8
(18.4)
|
| Comfort at end of day |
80.1
(22.7)
|
79.2
(22.7)
|
| Ease of handling/insertion |
86.3
(17.8)
|
91.7
(17.8)
|
| Ease of handling/removal |
90.7
(13.0)
|
93.2
(13.0)
|
| Dryness |
83.0
(19.8)
|
81.8
(19.8)
|
| Itchiness |
90.2
(16.2)
|
90.4
(16.2)
|
| Redness |
92.1
(11.3)
|
93.1
(11.3)
|
| Vision upon insertion |
88.1
(14.8)
|
92.7
(14.8)
|
| Vision |
88.3
(14.8)
|
90.7
(14.8)
|
| Vision in low light |
86.9
(14.9)
|
88.6
(14.9)
|
| Lens cleanness upon insertion |
91.6
(12.2)
|
93.4
(12.2)
|
| Lens cleanness upon removal |
87.4
(17.6)
|
89.5
(17.6)
|
| Overall impression |
83.9
(19.4)
|
84.5
(19.4)
|
| Lens cleanness |
87.9
(17.0)
|
89.6
(17.0)
|
Adverse Events
| Time Frame | 2 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were not coded. Therefore source vocabulary is not applicable. | |||
| Arm/Group Title | Investigational Lens | Air Optix Aqua Lens | ||
| Arm/Group Description | Bausch & Lomb investigational silicone hydrogel lens Investigational lens: Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week. | Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week. | ||
All Cause Mortality |
||||
| Investigational Lens | Air Optix Aqua Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Investigational Lens | Air Optix Aqua Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/66 (0%) | 0/66 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Investigational Lens | Air Optix Aqua Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/66 (0%) | 0/66 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Contact sponsor directly for details.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Bausch Health |
| Phone | |
| robert.steffen@bausch.com |
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01309906
Other Study ID Numbers:
- 688E
First Posted:
Mar 7, 2011
Last Update Posted:
Oct 22, 2020
Last Verified:
Sep 1, 2020