Trial Outcomes & Findings for Evaluation of the Feasibility a New Silicone Hydrogel Contact Lens (NCT NCT01309906)

NCT ID: NCT01309906

Last Updated: 2020-10-22

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

66 participants

Primary outcome timeframe

At 1 week follow up

Results posted on

2020-10-22

Participant Flow

A total of 66 participants (132 eyes) were enrolled in the study. One-half were randomized to receive the investigational lens, and the other half were randomized to receive the control lens. After one week of wearing the first lens type, the subjects returned for an exam and crossed over to the second lens type for one week.

Participant milestones

Participant milestones
Measure	Investigational Lens Then Air Optix Aqua Lens Bausch \& Lomb investigational silicone hydrogel lens Investigational lens: Bausch \& Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week. Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week.	Air Optix Aqua Lens Then Investigational Lens Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week. Bausch \& Lomb investigational silicone hydrogel lens Investigational lens: Bausch \& Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week.
Overall Study STARTED	33	33
Overall Study COMPLETED	32	32
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Feasibility a New Silicone Hydrogel Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=66 Participants All participants received both treatment groups.
Age, Continuous	31.1 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 1 week follow up

Population: There were 65 subjects (130 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 Lens n=130 eyes Bausch \& Lomb investigational silicone hydrogel lens Investigational lens: Bausch \& Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week.	Air Optix Aqua Lens n=130 eyes Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week.
Visual Acuity	-0.038 logMAR Standard Deviation 0.088	-0.040 logMAR Standard Deviation 0.088

SECONDARY outcome

Timeframe: At 1 week follow up

Population: There were 65 subjects (130 eyes) in each group 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 Lens n=130 eyes Bausch \& Lomb investigational silicone hydrogel lens Investigational lens: Bausch \& Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week.	Air Optix Aqua Lens n=130 eyes Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week.
Percentage of Eyes With > Grade 2 Slit Lamp Findings	0 eyes	0 eyes

SECONDARY outcome

Timeframe: At 1 week follow up

Population: There were 65 subjects (130 eyes) in each group for this outcome measure.

At 1-Week Follow-up, subjects were asked to rate 16 common symptoms/complaints on a scale of 0 to 100, with 100 being the most favorable score.

Outcome measures

Adverse Events

Investigational Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Air Optix Aqua 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

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

Measure	Investigational Lens n=130 eyes Bausch \& Lomb investigational silicone hydrogel lens Investigational lens: Bausch \& Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week.	Air Optix Aqua Lens n=130 eyes Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week.
Symptoms and Complaints Burning/stinging upon insertion	89.7 score on a scale Standard Deviation 16.7	90.5 score on a scale Standard Deviation 16.7
Symptoms and Complaints Comfort upon insertion	86.6 score on a scale Standard Deviation 18.9	86.9 score on a scale Standard Deviation 18.9
Symptoms and Complaints Overall comfort	85.7 score on a scale Standard Deviation 18.4	87.8 score on a scale Standard Deviation 18.4
Symptoms and Complaints Comfort at end of day	80.1 score on a scale Standard Deviation 22.7	79.2 score on a scale Standard Deviation 22.7
Symptoms and Complaints Ease of handling/insertion	86.3 score on a scale Standard Deviation 17.8	91.7 score on a scale Standard Deviation 17.8
Symptoms and Complaints Ease of handling/removal	90.7 score on a scale Standard Deviation 13.0	93.2 score on a scale Standard Deviation 13.0
Symptoms and Complaints Dryness	83.0 score on a scale Standard Deviation 19.8	81.8 score on a scale Standard Deviation 19.8
Symptoms and Complaints Itchiness	90.2 score on a scale Standard Deviation 16.2	90.4 score on a scale Standard Deviation 16.2
Symptoms and Complaints Redness	92.1 score on a scale Standard Deviation 11.3	93.1 score on a scale Standard Deviation 11.3
Symptoms and Complaints Vision upon insertion	88.1 score on a scale Standard Deviation 14.8	92.7 score on a scale Standard Deviation 14.8
Symptoms and Complaints Vision	88.3 score on a scale Standard Deviation 14.8	90.7 score on a scale Standard Deviation 14.8
Symptoms and Complaints Vision in low light	86.9 score on a scale Standard Deviation 14.9	88.6 score on a scale Standard Deviation 14.9
Symptoms and Complaints Lens cleanness upon insertion	91.6 score on a scale Standard Deviation 12.2	93.4 score on a scale Standard Deviation 12.2
Symptoms and Complaints Lens cleanness upon removal	87.4 score on a scale Standard Deviation 17.6	89.5 score on a scale Standard Deviation 17.6
Symptoms and Complaints Overall impression	83.9 score on a scale Standard Deviation 19.4	84.5 score on a scale Standard Deviation 19.4
Symptoms and Complaints Lens cleanness	87.9 score on a scale Standard Deviation 17.0	89.6 score on a scale Standard Deviation 17.0