Clinical Evaluation of 3 Contact Lens Materials With 3 So... | NCT03466060

NCT03466060

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
etafilcon A	Active Comparator	Eligible subjects were randomized to the etafilcon A lens in both eyes throughout the entire duration of the study.	Device: Opti-Free : RevitaLens / Clear Care : RevitaLens Device: Opti-Free : RevitaLens / RevitaLens : Clear Care Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens Device: Clear Care : RevitaLens / RevitaLens : Opti-Free Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens Device: RevitaLens : Clear Care / RevitaLens : Opti-Free Device: RevitaLens : Opti-Free / Clear Care : RevitaLens Device: RevitaLens : Opit-Free / RevitaLens : Clear Care
senofilcon A	Active Comparator	Eligible subjects were randomized to the senofilcon A lens in both eyes throughout the entire duration of the study.	Device: Opti-Free : RevitaLens / Clear Care : RevitaLens Device: Opti-Free : RevitaLens / RevitaLens : Clear Care Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens Device: Clear Care : RevitaLens / RevitaLens : Opti-Free Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens Device: RevitaLens : Clear Care / RevitaLens : Opti-Free Device: RevitaLens : Opti-Free / Clear Care : RevitaLens Device: RevitaLens : Opit-Free / RevitaLens : Clear Care
senofilcon C	Active Comparator	Eligible subjects were randomized to the senofilcon C lens in both eyes throughout the entire duration of the study.	Device: Opti-Free : RevitaLens / Clear Care : RevitaLens Device: Opti-Free : RevitaLens / RevitaLens : Clear Care Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Opti-Free : RevitaLens / Clear Care : RevitaLens	Device	Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subject Comfort	Subjective assessment of initial comfort was conducted using Visual Analogue Scale (VAS) of comfort. VAS of comfort consists of a vertical line which represents continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). VAS comfort was measured at 1-min, 5-min, 45-min, and 2-hours post-fit. The average comfort score for each solution was reported. This is a contralateral crossover, subject used the revitalens solution in one eye throughout the entire study therefore there are twice as many observations for revitalens compared to the other solutions.	Up to 2-Hours Post Lens Fitting

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
1. Subjects must be 18-69 years of age (inclusive).
2. Subjects must be habitual disposable hydrogel or silicone hydrogel (1-day, 2-week, or monthly replacement schedule) soft lens wearer in both eyes. Habitual is defined as at least one (1) month of contact lens wear where the lenses are worn for a minimum of six (6) hours per day and a minimum of five (5) days per week.
3. Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
4. The subject's refractive sphere (vertexed) must be between -1.00 and -6.00 D in each eye.
5. The subject's refractive cylinder must be less than or equal to -1.00 D in each eye.
6. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
7. Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
8. Subjects must read, understand, and sign the Statement of Informed Consent.
9. Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  
  Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
1. Currently pregnant or breast-feeding.
2. Diabetes
3. Any ocular or systemic allergies or disease which may interfere with contact lens wear (at the discretion of the investigator).
4. Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (eg, HIV), by self-report.
6. Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).
7. Grade 2 or greater corneal staining or conjunctival injection on the FDA scale.
8. Clinically significant (Grade 3 or greater on the FDA scale) corneal edema, corneal vascularization, or any other abnormalities of the cornea (excluding corneal staining) which would contraindicate contact lens wear.
9. Clinically significant (Grade 3 or greater on the FDA scale) tarsal abnormalities which might interfere with contact lens wear.
10. Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
11. Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.
12. History of any ocular or corneal surgery (eg, RK, PRK, LASIK).
13. Habitual contact lens wear modality as extended wear.
14. Participation in any pharmaceutical or medical device related clinical trial within 7 days prior to study enrollment.
15. History of binocular vision abnormality or strabismus.
16. Habitual wearers of rigid gas permeable lens within the past 3 months.
17. Employees of investigational clinic (investigator, coordinator, and technician etc.) or family members of employees of the investigational clinic by self-report

Facility	Status	City	State	ZIP	Country	Contacts
Southern California College of Optometry		Anaheim	California	92807	United States
University of California, Berkeley School of Optometry

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Etafilcon A-Opti-Free/Clear Care	Subjects that were dispensed the etafilcon A lens throughout the entire study and received Opti-Free in one eye during first period and Clear in one eye during second period. During both periods Revitalens was received on the contralateral eye.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 8, 2018

ID	Title	Description
BG000	Etafilcon A	Subjects that wore the etafilcon A lens during the entire study.
BG001	Senofilcon A	Subjects that wore the senofilcon A lens during the entire study.
BG002	Senofilcon C	Subjects that wore the senofilcon C lens during the entire study.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00037 BG00138 BG00238 BG003113

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Subject Comfort

Subjective assessment of initial comfort was conducted using Visual Analogue Scale (VAS) of comfort. VAS of comfort consists of a vertical line which represents continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). VAS comfort was measured at 1-min, 5-min, 45-min, and 2-hours post-fit. The average comfort score for each solution was reported. This is a contralateral crossover, subject used the revitalens solution in one eye throughout the entire study therefore there are twice as many observations for revitalens compared to the other solutions.

All subjects who successfully completed all study visits without a major protocol deviation.

Posted

Mean

Standard Deviation

Units on a scale

Up to 2-Hours Post Lens Fitting

Eyes

ID	Title	Description
OG000	Revita- Lens	All subject eyes that wore contact lenses pre-soaked in Revita-lens solution up to 2 hours regardless of the lens type.
OG001	Clear Care	All subject eyes that wore contact lenses pre-soaked in Clear Care solution up to 2 hours regardless of the lens type.
OG002	Opti-Free	All subjects eyes that wore contact lenses pre-soaked in Opit-Free solution up to 2 hours regardless of the lens type.

Units	Counts
Participants	OG00078 OG00178 OG00278
Eyes	OG000

Title

Denominators

Categories

1-Minute Follow-up

Title	Measurements
	OG00092.4± 11.74 OG00192.4± 10.52 OG00292.0± 10.58

5-Minute Follow-up

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	1-Minute Follow-up Analysis	bayesian multivariate hierarachical			95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.	Posterior mean difference	-2.1	Standard Deviation	2.23	2-Sided	95	-6.4	2.3			Posterior mean difference was calculated as Test-Control.		Superiority

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Etafilcon A - Revitalens	Subjects that wore the etaiflcon A lens throughout the entire duration of the study and the revitalens solution in at least one eye throughout the entire study.	37	37	37
EG001	Etafilcon A - Clear Care	Subjects that wore the etaiflcon A lens throughout the entire duration of the study and the Clear Care solution in one duringeither period 1 or period 2 during the study.	37	37	37
EG002	Etafilcon A- Optifree	Subjects that wore the etaiflcon A lens throughout the entire duration of the study and the OPti-Free solution in one duringeither period 1 or period 2 during the study.	37	37	37
EG003	Senofilcon A - Revitalens	Subjects that wore the senfilcon A lens throughout the entire duration of the study and the revitalens solution in at least one eye throughout the entire study.	38	38	38
EG004	Senofilcon A - ClearCare	Subjects that wore the senofilcon A lens throughout the entire duration of the study and the Clear Care solution in one duringeither period 1 or period 2 during the study.	38	38	38
EG005	Senofilcon A - Opti-Free	Subjects that wore the senofilcon A lens throughout the entire duration of the study and the Opti-Free solution in one duringeither period 1 or period 2 during the study.	38	38	38
EG006	Senofilcon C- Revitalens	Subjects that wore the senofilcon C lens throughout the entire duration of the study and the revitalens solution in at least one eye throughout the entire study.	38	38	38
EG007	Senofilcon C - ClearCare	Subjects that wore the senofilcon C lens throughout the entire duration of the study and the Clear Care solution in one duringeither period 1 or period 2 during the study.	38	38	38
EG008	Senofilcon C - OptiFree	Subjects that wore the senofilcon C lens throughout the entire duration of the study and the Opti-Free solution in one duringeither period 1 or period 2 during the study.	38	38	38