Trial Outcomes & Findings for A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses (NCT NCT01309867)

NCT ID: NCT01309867

Last Updated: 2020-10-08

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

302 participants

Primary outcome timeframe

2 weeks

Results posted on

2020-10-08

Participant Flow

A total of 151 participants (302 eyes) were randomized to receive test contact lenses and 151 participants (302 eyes) were randomized to receive control contact lenses. After two weeks of wearing the first lens type, the participants crossed over to the second lens type for two weeks.

Participant milestones

Participant milestones
Measure	Investigational Toric Lens Then PureVision Toric Lens Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch \& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks. Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch \& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.	PureVision Toric Lens Then Investigational Toric Lens Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch \& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks. Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch \& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.
Overall Study STARTED	151	151
Overall Study COMPLETED	148	139
Overall Study NOT COMPLETED	3	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=302 Participants Participants were randomized 1:1 to receive test contact lenses or control contact lenses. After two weeks of wearing the first lens type, the participants crossed over to the second lens type for two weeks.
Age, Continuous	34.9 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	208 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: There were 518 eyes in each group for this outcome measure.

Outcome measures

Outcome measures
Measure	Investigational Toric Lens n=518 eyes Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch \& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.	PureVision Toric Lens n=518 eyes Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch \& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.
Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees.	489 eyes	426 eyes

PRIMARY outcome

Timeframe: 2 weeks

Population: There were 518 eyes in each group for this outcome measure.

Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

Outcome measures

Outcome measures
Measure	Investigational Toric Lens n=518 eyes Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch \& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.	PureVision Toric Lens n=518 eyes Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch \& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.
Visual Acuity	-0.025 logMAR Standard Deviation 0.106	-0.021 logMAR Standard Deviation 0.106

SECONDARY outcome

Timeframe: 2 weeks

Population: There were 571 eyes in each group assess for this outcome measure.

Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression.

Outcome measures

Outcome measures
Measure	Investigational Toric Lens n=571 eyes Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch \& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.	PureVision Toric Lens n=571 eyes Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch \& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.
Symptoms and Complaints Burning/stinging upon insertion	85.4 score on a scale Standard Deviation 28.1	82.0 score on a scale Standard Deviation 28.1
Symptoms and Complaints Comfort upon insertion	77.7 score on a scale Standard Deviation 29.4	74.3 score on a scale Standard Deviation 29.4
Symptoms and Complaints Overall comfort	77.3 score on a scale Standard Deviation 29.6	67.9 score on a scale Standard Deviation 29.6
Symptoms and Complaints Comfort at the end of the day	67.8 score on a scale Standard Deviation 33.6	57.6 score on a scale Standard Deviation 33.6
Symptoms and Complaints Ease of handling/insertion	84.4 score on a scale Standard Deviation 25.2	80.9 score on a scale Standard Deviation 25.2
Symptoms and Complaints Ease of handling/removal	87.6 score on a scale Standard Deviation 23.0	83.7 score on a scale Standard Deviation 23.0
Symptoms and Complaints Dryness	73.6 score on a scale Standard Deviation 32.1	66.3 score on a scale Standard Deviation 32.1
Symptoms and Complaints Itchiness	86.6 score on a scale Standard Deviation 26.0	82.0 score on a scale Standard Deviation 26.0
Symptoms and Complaints Redness	88.0 score on a scale Standard Deviation 23.9	83.5 score on a scale Standard Deviation 23.9
Symptoms and Complaints Vision	82.0 score on a scale Standard Deviation 28.3	73.9 score on a scale Standard Deviation 28.3
Symptoms and Complaints Lens Cleanliness	86.1 score on a scale Standard Deviation 22.1	83.5 score on a scale Standard Deviation 22.1
Symptoms and Complaints Overall impression	74.4 score on a scale Standard Deviation 30.3	64.2 score on a scale Standard Deviation 30.3

SECONDARY outcome

Timeframe: 2 weeks

Population: There were 600 eyes with non-missing scores in both groups for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Investigational Toric Lens n=600 eyes Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch \& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.	PureVision Toric Lens n=600 eyes Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch \& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.
Percentage of Eyes With > Grade 2 Slit Lamp Findings	1 eyes	1 eyes

Adverse Events

Investigational Toric Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PureVision 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

Study Director

Bausch Health

Phone: 585-338-6399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER