Clinical Evaluation of Two Approved Contact Lenses

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02759692

Enrollment

283

Registered

2016-05-03

Start date

2016-04-01

Completion date

2016-06-01

Last updated

2017-08-18

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

Conditions

Visual Acuity

Brief summary

Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical performance of two FDA-approved contact lens.

Interventions

DEVICETEST Contact Lens

DEVICECONTROL Contact Lens

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 39 Years

Healthy volunteers

Yes

Inclusion criteria

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. The subject must be between (and including) 18 and 39 years of age. 4. The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day, worn for at least 30 days immediately preceding the study. 5. Have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -1.00 to -6.00 Diopters (D) in each eye. 6. Have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye. 7. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion criteria

1. Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued). 2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. Any autoimmune disease or use of medication, which may interfere with contact lens wear. 4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia. 5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.). 6. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. 7. Any ocular infection. 8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 9. Monovision, multi-focal, toric, or extended wear contact lens correction. 10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. 11. History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear. 12. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.

Design outcomes

Primary

Measure	Time frame	Description
Overall Comfort	7-Day Follow-up	Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.
Overall Quality of Vision	7-Day Follow-up	Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.

Secondary

Measure	Time frame	Description
Individual Patient Reported Outcomes (Items 1-5)	7-Day Follow-up	Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: (\[\] indicate the question was abbreviated due to space)1.These Lenses Were Very Comfortable At The End Of The Day 2.The Comfort of these lenses decreased throughout the day 3. The lenses were very comfortable from the time I got up to the time I went to bed 4. Overall Comfort 5. Comfort throughout the Day
Individual Patient Reported Outcomes (Items 6-10)	7-Day Follow-up	Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: (\[\] indicate the question was abbreviated due to space)6. Comfort at the end of the day 7. They remained comfortable from the moment I put them in until the moment I took them out 8.Comfort from activity to activity 9. Comfort across different environments 10.Comfort while working on a computer
Individual Patient Reported Outcomes (Items 11-14)	7-Day Follow-up	Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: (\[\] indicate the question was abbreviated due to space). 11.I was very satisfied with my distance vision when i first put these lenses in my eyes. 12.I was very satisfied by the clarity of my vision at the end of the day 13.I was satisfied with the quality of my vision at night 14.With these lenses, I felt very confident to drive at night
Individual Patient Reported Outcomes (Items 15-17)	7-Day Follow-up	Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: (\[\] indicate the question was abbreviated due to space). 15.Clarity of vision during daily activities 16.Clarity of vision in dim or low lighting conditions 17. Clarity of visions when driving at night.

Countries

United States

Participant flow

Pre-assignment details

A total of 283 subjects were enrolled into this study. Of the enrolled subjects all were dispensed at least one study lens. Of the dispensed subjects 276 subjects completed the study and 7 subjects were discontinued.

Participants by arm

Arm	Count
Dispensed Subjects All subjects that were dispensed at least one study lens.	276
Total	276

Withdrawals & dropouts

Period	Reason	FG000	FG001
Period 1	Miss-Randomized	1	1
Period 1	No longer meets eligibility criteria.	1	0
Period 1	Test article no longer available	1	1
Period 2	Lost to Follow-up	1	0
Period 2	Test article no longer available	0	1

Baseline characteristics

Characteristic	Dispensed Subjects
Age, Continuous	28.0 Years STANDARD_DEVIATION 5.75
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants
Race/Ethnicity, Customized Asian	8 Participants
Race/Ethnicity, Customized Black or African American	30 Participants
Race/Ethnicity, Customized White	237 Participants
Region of Enrollment United States	276 Participants
Sex: Female, Male Female	184 Participants
Sex: Female, Male Male	92 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 141	0 / 142
serious Total, serious adverse events	0 / 141	1 / 142

Outcome results

Primary

Overall Comfort

Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.

Time frame: 7-Day Follow-up