Trial Outcomes & Findings for Product Performance of a Toric Contact Lens (NCT NCT00658996)

NCT ID: NCT00658996

Last Updated: 2011-12-12

Results Overview

1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 220 participants
• Primary outcome timeframe: Over-all follow-up visits for 2 week period
• Results posted on: 2011-12-12

Participant Flow

This 4-week study was conducted at 12 sites in Asia. First participant enrolled 4/16/08, last participant visit was 6/20/08

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.

Participant milestones

Measure	SofLens DD Toric First, Then Focus Dailies Toric Bausch \& Lomb SofLens Daily Disposable Toric Contact Lens first then crossover to Ciba Vision Focus Dailies Toric Lens	Focus Dailies Toric First, Then SofLens DD Toric Ciba Vision Focus Dailies Toric Lens first, then crossover to Bausch \& Lomb SofLens Daily Disposable Toric Contact Lens
First Intervention STARTED	109	107
First Intervention COMPLETED	108	106
First Intervention NOT COMPLETED	1	1
Crossover Period STARTED	108	106
Crossover Period COMPLETED	106	105
Crossover Period NOT COMPLETED	2	1
Second Intervention STARTED	106	105
Second Intervention COMPLETED	105	104
Second Intervention NOT COMPLETED	1	1

Reasons for withdrawal

Measure	SofLens DD Toric First, Then Focus Dailies Toric Bausch \& Lomb SofLens Daily Disposable Toric Contact Lens first then crossover to Ciba Vision Focus Dailies Toric Lens	Focus Dailies Toric First, Then SofLens DD Toric Ciba Vision Focus Dailies Toric Lens first, then crossover to Bausch \& Lomb SofLens Daily Disposable Toric Contact Lens
First Intervention Positive slit lamp finding	1	0
First Intervention Lack of lenses	0	1
Crossover Period Physician Decision	1	0
Crossover Period Ineligible	1	1
Second Intervention Developed a stye on upper lid	1	0
Second Intervention Positive slit lamp finding	0	1

Baseline Characteristics

Product Performance of a Toric Contact Lens

Baseline characteristics by cohort

Measure	Entire Study Population n=216 Participants Population enrolled at start of study
Age Continuous	28.7 Years STANDARD_DEVIATION 7.19 • n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants
Race/Ethnicity, Customized Asian	216 participants n=5 Participants
Race/Ethnicity, Customized White	0 participants n=5 Participants
Race/Ethnicity, Customized Black	0 participants n=5 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants

PRIMARY outcome

Timeframe: Over-all follow-up visits for 2 week period

Population: All eligible, dispensed eyes, Overall follow-up visits.

1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.

Outcome measures

Measure	SofLens DD Toric n=213 Participants Bausch \& Lomb SofLens Daily Disposable Toric Contact Lens	Focus Dailies Toric n=210 Participants Ciba Vision Focus Dailies Toric contact lenses
Symptoms and Complaints Lens Cleanliness	87.5 Scores on a Scale Standard Deviation 12.7	86.5 Scores on a Scale Standard Deviation 13.0
Symptoms and Complaints Comfort	79.3 Scores on a Scale Standard Deviation 17.1	77.7 Scores on a Scale Standard Deviation 17.6
Symptoms and Complaints End of Day Comfort	73.5 Scores on a Scale Standard Deviation 19.6	71.5 Scores on a Scale Standard Deviation 19.9
Symptoms and Complaints Lens Awareness	78.8 Scores on a Scale Standard Deviation 17.9	75.6 Scores on a Scale Standard Deviation 20.4
Symptoms and Complaints Irritation	83.0 Scores on a Scale Standard Deviation 15.6	79.3 Scores on a Scale Standard Deviation 19.6
Symptoms and Complaints Itching	86.4 Scores on a Scale Standard Deviation 14.9	83.9 Scores on a Scale Standard Deviation 17.2
Symptoms and Complaints Dryness	77.4 Scores on a Scale Standard Deviation 18.0	73.7 Scores on a Scale Standard Deviation 20.3
Symptoms and Complaints Redness	86.3 Scores on a Scale Standard Deviation 14.9	81.5 Scores on a Scale Standard Deviation 19.5
Symptoms and Complaints Vision	77.1 Scores on a Scale Standard Deviation 19.1	84.3 Scores on a Scale Standard Deviation 14.6
Symptoms and Complaints Lens Handling	87.4 Scores on a Scale Standard Deviation 13.0	76.1 Scores on a Scale Standard Deviation 21.2
Symptoms and Complaints Overall Impression	78.7 Scores on a Scale Standard Deviation 16.2	75.9 Scores on a Scale Standard Deviation 17.5

PRIMARY outcome

Timeframe: Over-all follow-up visits, 2 weeks

Population: All eligible, dispensed eyes

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.

Outcome measures

Measure	SofLens DD Toric n=426 eyes Bausch \& Lomb SofLens Daily Disposable Toric Contact Lens	Focus Dailies Toric n=420 eyes Ciba Vision Focus Dailies Toric contact lenses
Contact Lens High Contrast Visual Acuity	-0.007 LogMAR Standard Deviation 0.0669	-0.014 LogMAR Standard Deviation 0.0696

SECONDARY outcome

Timeframe: Over-all follow-up visits, 2 weeks

Population: All dispensed eyes, over all follow-up visits

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

Outcome measures

Measure	SofLens DD Toric n=430 eyes Bausch \& Lomb SofLens Daily Disposable Toric Contact Lens	Focus Dailies Toric n=430 eyes Ciba Vision Focus Dailies Toric contact lenses
Slit Lamp Findings Slit Lamp Findings > Grade 2	0 Eyes	2 Eyes
Slit Lamp Findings Slit Lamp Findings </= Grade 2	430 Eyes	428 Eyes

Adverse Events

SofLens DD Toric

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ciba Vision Toric 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

Gerard Cairns, PhD, MCOptom

Bausch & Lomb Incorporated

Phone: (585) 338-5170

Email: gerard.cairns@bausch.com

Results disclosure agreements

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

Restriction type: OTHER