A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02345811

Enrollment

Registered

2015-01-26

Start date

2015-01-31

Completion date

2015-03-31

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperopia, Myopia

Brief summary

To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.

Detailed description

This was a randomized, bilateral, 2 week cross over, double-masked, dispensing study comparing Sapphire test lens against the senofilcon A control lens. This study results were not used to support design validation of the test lens.

Interventions

DEVICESapphire

silicone-hydrogel contact lens

DEVICEsenofilcon A

contact lens

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

Inclusion criteria

* Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer * Has read and signed an information consent letter * Is willing and able to follow instructions and maintain the appointment schedule; * Is an adapted soft contact lens wearer * Requires spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps) * Has no more than 0.75 diopters of refractive astigmatism * Willing to wear contact lens in both eyes * Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye * To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable

Exclusion criteria

* Is participating in any concurrent clinical or research study * Has any known active\* ocular disease and/or infection * Has a systemic condition that in the opinion of the investigator may affect a study outcome variable * Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable * Has known sensitivity to the diagnostic pharmaceuticals to be used in the study * Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit) * Is aphakic * Has undergone refractive error surgery

Design outcomes

Primary

Measure	Time frame	Description
Subjective Preference for Comfort.	Baseline - 10 minutes post lens settling	Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Vision Quality	Baseline (10 minutes post lens settling at dispense)	Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Subjective Rating for Comfort.	Baseline - 10 minutes post lens settling	Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Lens Surface Wettability	Baseline (10 minutes post lens settling)	Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)
Surface Deposits	Baseline (10 minutes post lens settling)	Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = \<5 deposits; 2 = \>5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits \>0.5mm or film \> 75% of surface)
Lens Handling (Ease of Insertion)	2 weeks	Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye.
Lens Handling (Ease of Removal)	2 weeks	Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye.

Countries

Canada, United States

Participant flow

Participants by arm

Arm	Count
Overall Study Subjects were randomized to wear either the test lens or the control lens for 2 weeks and then cross-over to the other lens. Test Lens: Sapphire (contact lens) Control Lens : Senofilcon A (contact lens)	32
Total	32

Withdrawals & dropouts

Period	Reason	FG000	FG001
First Intervention	Withdrawal by Subject	1	1

Baseline characteristics

Characteristic	Overall Study	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	32 Participants	—
Age, Continuous	24 years STANDARD_DEVIATION 9	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Canada	15 participants	—
Region of Enrollment United States	17 participants	—
Sex: Female, Male Female	25 Participants	—
Sex: Female, Male Male	7 Participants	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 32	0 / 32
other Total, other adverse events	2 / 32	2 / 32
serious Total, serious adverse events	0 / 32	0 / 32

Outcome results

Primary

Lens Handling (Ease of Insertion)

Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye.

Time frame: 2 weeks

Arm	Measure	Value (MEAN)	Dispersion
Sapphire	Lens Handling (Ease of Insertion)	93 units on a scale	Standard Deviation 10
Senofilcon A	Lens Handling (Ease of Insertion)	95 units on a scale	Standard Deviation 8

Primary

Lens Handling (Ease of Removal)

Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye.

Time frame: 2 weeks

Arm	Measure	Value (MEAN)	Dispersion
Sapphire	Lens Handling (Ease of Removal)	90 units on a scale	Standard Deviation 14
Senofilcon A	Lens Handling (Ease of Removal)	95 units on a scale	Standard Deviation 7

Primary

Lens Surface Wettability

Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)

Time frame: Baseline (10 minutes post lens settling)

Arm	Measure	Value (MEAN)	Dispersion
Sapphire	Lens Surface Wettability	3.2 units on a scale	Standard Deviation 0.6
Senofilcon A	Lens Surface Wettability	3.2 units on a scale	Standard Deviation 0.7

Primary

Lens Surface Wettability

Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)

Time frame: 2 weeks

Arm	Measure	Value (MEAN)	Dispersion
Sapphire	Lens Surface Wettability	3.0 units on a scale	Standard Deviation 0.8
Senofilcon A	Lens Surface Wettability	3.2 units on a scale	Standard Deviation 0.6

Primary