Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens (NCT NCT01130974)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

Summarized over all follow-up visits through 1 month

Results posted on

2013-12-10

Participant Flow

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

Of the 200 participants (400 eyes) enrolled and dispensed lenses, 172 participants (344 eyes) completed the study

Participant milestones

Participant milestones
Measure	Bausch & Lomb Contact Lens Bausch \& Lomb daily disposable cosmetic tint contact lens	Marketed Daily Disposable Contact Lens Marketed daily disposable cosmetic tint contact lens
Overall Study STARTED	100	100
Overall Study COMPLETED	85	87
Overall Study NOT COMPLETED	15	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Bausch & Lomb Contact Lens Bausch \& Lomb daily disposable cosmetic tint contact lens	Marketed Daily Disposable Contact Lens Marketed daily disposable cosmetic tint contact lens
Overall Study Protocol Violation	10	10
Overall Study Withdrawal by Subject	0	1
Overall Study Ineligibility criteria	5	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bausch & Lomb Contact Lens n=100 Participants Bausch \& Lomb daily disposable cosmetic tint contact lens	Marketed Daily Disposable Contact Lens n=100 Participants Marketed daily disposable cosmetic tint contact lens	Total n=200 Participants Total of all reporting groups
Age, Customized Between 18 and 62 years	100 participants n=93 Participants	100 participants n=4 Participants	200 participants n=27 Participants
Sex: Female, Male Female	74 Participants n=93 Participants	76 Participants n=4 Participants	150 Participants n=27 Participants
Sex: Female, Male Male	26 Participants n=93 Participants	24 Participants n=4 Participants	50 Participants n=27 Participants
Race/Ethnicity, Customized Asian Decent	100 participants n=93 Participants	100 participants n=4 Participants	200 participants n=27 Participants

PRIMARY outcome

Timeframe: Summarized over all follow-up visits through 1 month

Population: All dispensed eyes with any slit lamp findings \> grade 2

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

Outcome measures

Outcome measures
Measure	Bausch & Lomb Contact Lens n=198 eyes Bausch \& Lomb daily disposable cosmetic tint contact lens	Marketed Daily Disposable Contact Lens n=198 eyes Marketed daily disposable cosmetic tint contact lens
Slit Lamp Findings	0 eyes	0 eyes

PRIMARY outcome

Timeframe: Summarized over all visits, and dispensed visit

Population: All eligible, dispensed eyes

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

Outcome measures

Outcome measures
Measure	Bausch & Lomb Contact Lens n=172 eyes Bausch \& Lomb daily disposable cosmetic tint contact lens	Marketed Daily Disposable Contact Lens n=176 eyes Marketed daily disposable cosmetic tint contact lens
logMAR Visual Acuity (VA) All study visits	0.006 logMAR Standard Deviation 0.039	-0.009 logMAR Standard Deviation 0.039
logMAR Visual Acuity (VA) Dispensed visit	0.006 logMAR Standard Deviation 0.048	-0.010 logMAR Standard Deviation 0.048

PRIMARY outcome

Timeframe: 2 week and 1 month follow-up

Population: All eligible, dispensed eyes

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

Outcome measures

Outcome measures
Measure	Bausch & Lomb Contact Lens n=170 eyes Bausch \& Lomb daily disposable cosmetic tint contact lens	Marketed Daily Disposable Contact Lens n=174 eyes Marketed daily disposable cosmetic tint contact lens
logMAR Visual Acuity (VA) 2 week visit	0.010 logMAR Standard Deviation 0.046	-0.004 logMAR Standard Deviation 0.046
logMAR Visual Acuity (VA) 1 month visit	0.003 logMAR Standard Deviation 0.043	-0.013 logMAR Standard Deviation 0.043

SECONDARY outcome

Timeframe: Summarized over all follow-up visits through 1 month

Population: All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.

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.

Outcome measures

Outcome measures
Measure	Bausch & Lomb Contact Lens n=172 eyes Bausch \& Lomb daily disposable cosmetic tint contact lens	Marketed Daily Disposable Contact Lens n=176 eyes Marketed daily disposable cosmetic tint contact lens
Lens Wettability Optimal	129 eyes	134 eyes
Lens Wettability Slight	41 eyes	39 eyes
Lens Wettability Mild	2 eyes	3 eyes
Lens Wettability Moderate	0 eyes	0 eyes
Lens Wettability Severe	0 eyes	0 eyes

SECONDARY outcome

Timeframe: Summarized over all follow-up visits through one month

Population: All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.

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

Outcome measures

Outcome measures
Measure	Bausch & Lomb Contact Lens n=172 eyes Bausch \& Lomb daily disposable cosmetic tint contact lens	Marketed Daily Disposable Contact Lens n=174 eyes Marketed daily disposable cosmetic tint contact lens
Lens Deposits None	152 eyes	151 eyes
Lens Deposits Light	20 eyes	23 eyes
Lens Deposits Medium	0 eyes	0 eyes
Lens Deposits Heavy	0 eyes	0 eyes

SECONDARY outcome

Timeframe: Summarized over all follow-up visits through 1 month

Population: All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.

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.

Outcome measures

Outcome measures
Measure	Bausch & Lomb Contact Lens n=172 eyes Bausch \& Lomb daily disposable cosmetic tint contact lens	Marketed Daily Disposable Contact Lens n=176 eyes Marketed daily disposable cosmetic tint contact lens
Lens Centration Excellent	127 eyes	129 eyes
Lens Centration Good	31 eyes	26 eyes
Lens Centration Fair	13 eyes	6 eyes
Lens Centration Poor	1 eyes	15 eyes

SECONDARY outcome

Timeframe: Summarized over all follow-up visits through one month

Population: All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.

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.

Outcome measures

Outcome measures
Measure	Bausch & Lomb Contact Lens n=172 eyes Bausch \& Lomb daily disposable cosmetic tint contact lens	Marketed Daily Disposable Contact Lens n=176 eyes Marketed daily disposable cosmetic tint contact lens
Lens Movement Adequate	167 eyes	152 eyes
Lens Movement Excessive	0 eyes	18 eyes
Lens Movement Insufficient	5 eyes	6 eyes
Lens Movement Adherence	0 eyes	0 eyes

SECONDARY outcome

Timeframe: Summarized over all follow-up visits through one month

Population: All eligible dispensed eyes, summarized over all follow-up visits through 1 month.

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.

Outcome measures

Outcome measures
Measure	Bausch & Lomb Contact Lens n=172 eyes Bausch \& Lomb daily disposable cosmetic tint contact lens	Marketed Daily Disposable Contact Lens n=176 eyes Marketed daily disposable cosmetic tint contact lens
Symptoms & Complaints Burning Stinging Upon Insertion	90.3 units on a scale Standard Deviation 12.9	84.6 units on a scale Standard Deviation 12.9
Symptoms & Complaints Comfort	87.1 units on a scale Standard Deviation 13.1	83.1 units on a scale Standard Deviation 13.1
Symptoms & Complaints End of Day Comfort	82.0 units on a scale Standard Deviation 15.1	77.3 units on a scale Standard Deviation 15.1
Symptoms & Complaints Lens Awareness	88.7 units on a scale Standard Deviation 12.9	80.6 units on a scale Standard Deviation 12.9
Symptoms & Complaints Lens Cleanliness	91.9 units on a scale Standard Deviation 8.4	89.2 units on a scale Standard Deviation 8.4
Symptoms & Complaints Irritation	87.4 units on a scale Standard Deviation 12.9	82.8 units on a scale Standard Deviation 12.9
Symptoms & Complaints Itching	89.3 units on a scale Standard Deviation 13.3	84.6 units on a scale Standard Deviation 13.3
Symptoms & Complaints Dryness	82.1 units on a scale Standard Deviation 15.7	77.9 units on a scale Standard Deviation 15.6
Symptoms & Complaints Redness	89.4 units on a scale Standard Deviation 12.8	85.4 units on a scale Standard Deviation 12.8
Symptoms & Complaints Vision	89.6 units on a scale Standard Deviation 11.4	87.9 units on a scale Standard Deviation 11.4
Symptoms & Complaints Lens Handling Upon Insertion	89.2 units on a scale Standard Deviation 13.0	83.3 units on a scale Standard Deviation 13.0
Symptoms & Complaints Lens Handling Upon Removal	92.1 units on a scale Standard Deviation 10.1	87.9 units on a scale Standard Deviation 10.1
Symptoms & Complaints Overall Impression	87.5 units on a scale Standard Deviation 12.8	80.1 units on a scale Standard Deviation 12.8

Adverse Events

Bausch & Lomb Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Marketed Daily Disposable Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Steffen

Bausch & Lomb Inc.

Phone: (585) 338-6399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER