A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02555098

Enrollment

Registered

2015-09-21

Start date

2015-09-30

Completion date

2016-04-30

Last updated

2020-10-19

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

Conditions

Astigmatism

Brief summary

This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens. The study results were not used for design validation of the investigational product.

Detailed description

This will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism control lens.

Interventions

DEVICESapphire contact lenses

Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

DEVICEsenofilcon A contact lenses

Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* A person is eligible for inclusion in the study if they: 1. Are at least 18 years of age and have full legal capacity to volunteer; 2. Have read and signed an information consent letter; 3. Are willing and able to follow instructions and maintain the appointment schedule; 4. Are an adapted soft contact lens wearer; 5. Require spectacle lens powers in both eyes; 1. Sphere: between -1.75 to -6.00 diopters and 2. Astigmatism: between -1.00 to -2.25 and 3. Axis: 180 ± 20 degrees 6. Are willing to wear contact lenses in both eyes; 7. Have manifest refraction visual acuities (VA) equal to or better than logMAR (log of the minimum angle of resolution) equivalent of 20/25 in each eye; 8. 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 including toric orientation as acceptable.

Exclusion criteria

* A person will be excluded from the study if they: 1. Are participating in any concurrent clinical or research study; 2. Have any known active\* ocular disease and/or infection; 3. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study; 6. Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); 7. Are aphakic; 8. Have undergone refractive error surgery;

Design outcomes

Primary

Measure	Time frame	Description
Subjective Ratings for Comfort	Baseline (10 minutes post lens settling)	Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)
Subjective Ratings for Comfort Preference	Baseline (10 minutes post lens settling)	Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference
Subjective Assessment of Visual Quality	Baseline (10 minutes post lens settling)	Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)
Subjective Assessment of Overall Satisfaction	Baseline (10 minutes post lens settling)	Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)
Subjective Overall Preference	Baseline (10 minutes post lens settling)	Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference

Countries

United States

Participant flow

Participants by arm

Arm	Count
Overall Study Each subject randomized to wear either the Sapphire lenses (test) or senofilcon A contact lenses (control) as a matched pair for two weeks and cross over to the second matched pair for two weeks.	23
Total	23

Baseline characteristics

Characteristic	Overall Study	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	23 Participants	—
Age, Continuous	40 years STANDARD_DEVIATION 11	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	23 participants	—
Sex: Female, Male Female	20 Participants	—
Sex: Female, Male Male	3 Participants	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 23	0 / 23
other Total, other adverse events	0 / 23	0 / 23
serious Total, serious adverse events	0 / 23	0 / 23

Outcome results

Primary

Subjective Assessment of Overall Satisfaction

Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)

Time frame: 2 weeks

Population: One subject was excluded from the analysis due to compliance

Arm	Measure	Value (MEAN)	Dispersion
Sapphire Lenses	Subjective Assessment of Overall Satisfaction	87 units on a scale	Standard Deviation 14
Senofilcon A	Subjective Assessment of Overall Satisfaction	73 units on a scale	Standard Deviation 30

Primary

Subjective Assessment of Overall Satisfaction

Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)

Time frame: Baseline (10 minutes post lens settling)

Population: One subject was excluded from the analysis due to compliance

Arm	Measure	Value (MEAN)	Dispersion
Sapphire Lenses	Subjective Assessment of Overall Satisfaction	89 units on a scale	Standard Deviation 12
Senofilcon A	Subjective Assessment of Overall Satisfaction	81 units on a scale	Standard Deviation 21

Primary

Subjective Assessment of Visual Quality

Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)

Time frame: Baseline (10 minutes post lens settling)