Safety and Efficacy of a Contact Lens for Daily Disposable Use
Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01365039
Collaborator
(none)
173
1
2
4
43.2
Study Details
Study Description
Brief Summary
This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
173 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Official Title:
A Study to Evaluate the Safety and Efficacy of a Novel Contact Lens for Daily Disposable Use
Study Start Date
:
Jun 1, 2011
Actual Primary Completion Date
:
Oct 1, 2011
Actual Study Completion Date
:
Oct 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Test lens Test contact lens will be worn on a daily disposable wear basis. |
Device: Test, daily disposable contact lens
Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
|
| Active Comparator: SofLens lens The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. |
Device: SofLens daily disposable contact lens
Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
|
Outcome Measures
Primary Outcome Measures
- Slit Lamp Findings > Grade 2 [4 visits over 3 months]
Statistical non-inferiority of Slit Lamp Findings > Grade 2 at any visit between the Test and Control lenses
- High Contrast, Distance logMAR Visual Acuity (VA) [4 visits over 3 months]
Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye.
-
Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye.
-
Subjects must be free of any anterior segment disorders.
-
Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.
Exclusion Criteria:
-
Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
-
Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
-
Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
-
Subjects who have had any corneal surgery (eg, refractive surgery).
-
Subjects who are allergic to any component in the study care products.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bausch & Lomb, Inc. | Rochester | New York | United States | 14609 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Principal Investigator: Beverly Barna, CCRA, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01365039
Other Study ID Numbers:
- 690
First Posted:
Jun 3, 2011
Last Update Posted:
Jan 8, 2014
Last Verified:
Nov 1, 2013
Study Results
Participant Flow
| Recruitment Details | A total of 173 participants (346 eyes) were enrolled at 11 investigative sites in the United States (US), the first participant was enrolled in the study on 6/13/2011, the last participant exited the study on 10/1/2011. |
|---|---|
| Pre-assignment Detail | This was a 3 month randomized, parallel, bilateral, single-masked study. One participant discontinued the study. |
| Arm/Group Title | SofLens Lens | Test Lens |
|---|---|---|
| Arm/Group Description | The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. | Test contact lens will be worn on a daily disposable wear basis. Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. |
| Period Title: Overall Study | ||
| STARTED | 86 | 87 |
| COMPLETED | 85 | 87 |
| NOT COMPLETED | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | SofLens | Test Lens | Total |
|---|---|---|---|
| Arm/Group Description | The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. | Test contact lens will be worn on a daily disposable wear basis. Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. | Total of all reporting groups |
| Overall Participants | 86 | 87 | 173 |
| Age, Customized (participants) [Number] | |||
| Between 18 and 40 years |
86
100%
|
87
100%
|
173
100%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
64
74.4%
|
56
64.4%
|
120
69.4%
|
| Male |
22
25.6%
|
31
35.6%
|
53
30.6%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
86
100%
|
87
100%
|
173
100%
|
Outcome Measures
| Title | Slit Lamp Findings > Grade 2 |
|---|---|
| Description | Statistical non-inferiority of Slit Lamp Findings > Grade 2 at any visit between the Test and Control lenses |
| Time Frame | 4 visits over 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Over All Follow-up Visits, Eyes with Findings > Grade 2 (All Dispensed Eyes) |
| Arm/Group Title | SofLens Lens | Test Lens |
|---|---|---|
| Arm/Group Description | The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. | Test contact lens will be worn on a daily disposable wear basis. Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. |
| Measure Participants | 86 | 87 |
| Measure eyes | 172 | 174 |
| Number [eyes] |
0
|
1
|
| Title | High Contrast, Distance logMAR Visual Acuity (VA) |
|---|---|
| Description | Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint |
| Time Frame | 4 visits over 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Eligible, Dispensed Eyes |
| Arm/Group Title | SofLens | Test Lens |
|---|---|---|
| Arm/Group Description | The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. | Test contact lens will be worn on a daily disposable wear basis. Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. |
| Measure Participants | 86 | 87 |
| Measure eyes | 172 | 174 |
| Mean (Standard Deviation) [logMAR] |
-0.028
(0.040)
|
-0.025
(0.040)
|
Adverse Events
| Time Frame | 3 Months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | SofLens Lens | Test Lens | ||
| Arm/Group Description | The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. | Test contact lens will be worn on a daily disposable wear basis. Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. | ||
All Cause Mortality |
||||
| SofLens Lens | Test Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| SofLens Lens | Test Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/86 (0%) | 0/87 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| SofLens Lens | Test Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/86 (0%) | 0/87 (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 | Robert Steffen, OD, MS |
|---|---|
| Organization | Bausch & Lomb Incorporated |
| Phone | (585) 338-6399 |
| robert.steffen@bausch.com |
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01365039
Other Study ID Numbers:
- 690
First Posted:
Jun 3, 2011
Last Update Posted:
Jan 8, 2014
Last Verified:
Nov 1, 2013