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A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens

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ClinicalTrials.gov Identifier: NCT01130974
Recruitment Status : Completed
First Posted : May 26, 2010
Results First Posted : December 10, 2013
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myopia
Interventions Device: Bausch & Lomb contact lens
Device: Marketed daily disposable contact lens
Enrollment 200
Recruitment Details 200 Asian participants (400 eyes) who were adapted wearers of soft contact lenses were enrolled in this 1-month study at approximately 10 investigative sites in Asia and the United States. First participant was enrolled 4/12/2010 and last participant exited the study 08/09/2010
Pre-assignment Details Of the 200 participants (400 eyes) enrolled and dispensed lenses, 172 participants (344 eyes) completed the study
Arm/Group Title Bausch & Lomb Contact Lens Marketed Daily Disposable Contact Lens
Hide Arm/Group Description Bausch & Lomb daily disposable cosmetic tint contact lens Marketed daily disposable cosmetic tint contact lens
Period Title: Overall Study
Started 100 100
Completed 85 87
Not Completed 15 13
Reason Not Completed
Protocol Violation             10             10
Withdrawal by Subject             0             1
Ineligibility criteria             5             2
Arm/Group Title Bausch & Lomb Contact Lens Marketed Daily Disposable Contact Lens Total
Hide Arm/Group Description Bausch & Lomb daily disposable cosmetic tint contact lens Marketed daily disposable cosmetic tint contact lens Total of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
All participants were randomized and dispensed lenses at the baseline visit.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Between 18 and 62 years Number Analyzed 100 participants 100 participants 200 participants
100 100 200
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
74
  74.0%
76
  76.0%
150
  75.0%
Male
26
  26.0%
24
  24.0%
50
  25.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian Decent Number Analyzed 100 participants 100 participants 200 participants
100 100 200
1.Primary Outcome
Title Slit Lamp Findings
Hide Description Graded Slit lamp findings (epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates) > grade 2 over all follow-up visits, summarizes the worst case over all follow-up visits. Graded 0-4 with 0=none and 4=severe
Time Frame Summarized over all follow-up visits through 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All dispensed eyes with any slit lamp findings > grade 2
Arm/Group Title Bausch & Lomb Contact Lens Marketed Daily Disposable Contact Lens
Hide Arm/Group Description:
Bausch & Lomb daily disposable cosmetic tint contact lens
Marketed daily disposable cosmetic tint contact lens
Overall Number of Participants Analyzed 99 99
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
198 198
Measure Type: Number
Unit of Measure: eyes
0 0
2.Primary Outcome
Title logMAR Visual Acuity (VA)
Hide Description Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit
Time Frame Summarized over all visits, and dispensed visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible, dispensed eyes
Arm/Group Title Bausch & Lomb Contact Lens Marketed Daily Disposable Contact Lens
Hide Arm/Group Description:
Bausch & Lomb daily disposable cosmetic tint contact lens
Marketed daily disposable cosmetic tint contact lens
Overall Number of Participants Analyzed 86 88
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
172 176
Mean (Standard Deviation)
Unit of Measure: logMAR
All study visits 0.006  (0.039) -0.009  (0.039)
Dispensed visit 0.006  (0.048) -0.010  (0.048)
3.Primary Outcome
Title logMAR Visual Acuity (VA)
Hide Description Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit
Time Frame 2 week and 1 month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible, dispensed eyes
Arm/Group Title Bausch & Lomb Contact Lens Marketed Daily Disposable Contact Lens
Hide Arm/Group Description:
Bausch & Lomb daily disposable cosmetic tint contact lens
Marketed daily disposable cosmetic tint contact lens
Overall Number of Participants Analyzed 85 87
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
170 174
Mean (Standard Deviation)
Unit of Measure: logMAR
2 week visit 0.010  (0.046) -0.004  (0.046)
1 month visit 0.003  (0.043) -0.013  (0.043)
4.Secondary Outcome
Title Lens Wettability
Hide Description Lens wettability was rated as Grade 4-0. Grade 4 = 100% of anterior surface wettable (optimal); Grade 3 = presence of small (< 0.1 mm), individual, discrete non-wetting areas (slight); Grade 2 = presence of single area of non-wetting between 0.1 mm and 0.5 mm in size (mild); Grade 1 = presence of several areas on non-wetting, each between 0.1 mm and 0.5 mm in size (moderate); Grade 0 = presence of one or more non-wetting areas > 0.5 mm in size (severe). Suboptimal lens wettability was defined as a rating other than Grade 4, ie slight, mild, moderate, or severe ratings. Over All Visits summarizes the worst case over the dispensing and all follow-up visits.
Time Frame Summarized over all follow-up visits through 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.
Arm/Group Title Bausch & Lomb Contact Lens Marketed Contact Lens
Hide Arm/Group Description:
Bausch & Lomb daily disposable cosmetic tint contact lens
Marketed daily disposable cosmetic tint contact lens
Overall Number of Participants Analyzed 86 88
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
172 176
Measure Type: Number
Unit of Measure: eyes
Optimal 129 134
Slight 41 39
Mild 2 3
Moderate 0 0
Severe 0 0
5.Secondary Outcome
Title Lens Deposits
Hide Description Degree of lens deposits was assessed as none, light, medium, or heavy. Suboptimal lens deposits were defined as a degree rating of medium or heavy. Measured over all visits through one month
Time Frame Summarized over all follow-up visits through one month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.
Arm/Group Title Bausch & Lomb Contact Lens Marketed Contact Lens
Hide Arm/Group Description:
Bausch & Lomb daily disposable cosmetic tint contact lens
Marketed daily disposable cosmetic tint contact lens
Overall Number of Participants Analyzed 86 87
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
172 174
Measure Type: Number
Unit of Measure: eyes
None 152 151
Light 20 23
Medium 0 0
Heavy 0 0
6.Secondary Outcome
Title Lens Centration
Hide Description

Lens centration was assessed as excellent(fully centered), good (slight decentration, no corneal exposure), fair (decentration, intermittent corneal exposure), or poor (incomplete corneal coverage and/or edge lift).

Suboptimal lens centration was defined as a rating other than excellent.

Time Frame Summarized over all follow-up visits through 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.
Arm/Group Title Bausch & Lomb Contact Lens Marketed Contact Lens
Hide Arm/Group Description:
Bausch & Lomb daily disposable cosmetic tint contact lens
Marketed daily disposable cosmetic tint contact lens
Overall Number of Participants Analyzed 86 88
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
172 176
Measure Type: Number
Unit of Measure: eyes
Excellent 127 129
Good 31 26
Fair 13 6
Poor 1 15
7.Secondary Outcome
Title Lens Movement
Hide Description Lens movement was assessed as adequate, excessive (> 0.6 mm), insufficient (< 0.2 mm), or adherence. Suboptimal lens movement was defined as a rating other than adequate.
Time Frame Summarized over all follow-up visits through one month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.
Arm/Group Title Bausch & Lomb Contact Lens Marketed Contact Lens
Hide Arm/Group Description:
Bausch & Lomb daily disposable cosmetic tint contact lens
Marketed daily disposable cosmetic tint contact lens
Overall Number of Participants Analyzed 86 88
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
172 176
Measure Type: Number
Unit of Measure: eyes
Adequate 167 152
Excessive 0 18
Insufficient 5 6
Adherence 0 0
8.Secondary Outcome
Title Symptoms & Complaints
Hide Description Subject symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting least favorable symptoms/complaints and 100 being the most favorable score.
Time Frame Summarized over all follow-up visits through one month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible dispensed eyes, summarized over all follow-up visits through 1 month.
Arm/Group Title Bausch & Lomb Contact Lens Marketed Daily Disposable Contact Lens
Hide Arm/Group Description:
Bausch & Lomb daily disposable cosmetic tint contact lens
Marketed daily disposable cosmetic tint contact lens
Overall Number of Participants Analyzed 86 88
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
172 176
Mean (Standard Deviation)
Unit of Measure: units on a scale
Burning Stinging Upon Insertion 90.3  (12.9) 84.6  (12.9)
Comfort 87.1  (13.1) 83.1  (13.1)
End of Day Comfort 82.0  (15.1) 77.3  (15.1)
Lens Awareness 88.7  (12.9) 80.6  (12.9)
Lens Cleanliness 91.9  (8.4) 89.2  (8.4)
Irritation 87.4  (12.9) 82.8  (12.9)
Itching 89.3  (13.3) 84.6  (13.3)
Dryness 82.1  (15.7) 77.9  (15.6)
Redness 89.4  (12.8) 85.4  (12.8)
Vision 89.6  (11.4) 87.9  (11.4)
Lens Handling Upon Insertion 89.2  (13.0) 83.3  (13.0)
Lens Handling Upon Removal 92.1  (10.1) 87.9  (10.1)
Overall Impression 87.5  (12.8) 80.1  (12.8)
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bausch & Lomb Contact Lens Marketed Daily Disposable Contact Lens
Hide Arm/Group Description Bausch & Lomb daily disposable cosmetic tint contact lens Marketed daily disposable cosmetic tint contact lens
All-Cause Mortality
Bausch & Lomb Contact Lens Marketed Daily Disposable Contact Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bausch & Lomb Contact Lens Marketed Daily Disposable Contact Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bausch & Lomb Contact Lens Marketed Daily Disposable Contact Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor,and such that confidential or proprietary information is not disclosed.
Results Point of Contact
Name/Title: Robert Steffen
Organization: Bausch & Lomb Inc.
Phone: (585) 338-6399
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01130974     History of Changes
Other Study ID Numbers: 639
First Submitted: May 25, 2010
First Posted: May 26, 2010
Results First Submitted: March 15, 2013
Results First Posted: December 10, 2013
Last Update Posted: December 10, 2013