Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01763047

Enrollment

298

Registered

2013-01-08

Start date

2012-11-30

Completion date

2013-02-28

Last updated

2018-06-19

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

Conditions

Presbyopia

Brief summary

The objective of this study is to evaluate the performance of a novel multifocal lens system.

Interventions

DEVICEetafilcon A

To be worn in a daily wear modality for a minimum of 6 hours per day.

DEVICElotrafilcon B

Lenses will be worn in a reuseable modality; cleaned and disinfected each night.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

1. Subjects must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol. 3. Subjects must be between 40 and 70 years of age. 4. Subjects' spherical equivalent distance refraction must be in the range of -3.75 to +3.75 in each eye. 5. Subjects' refractive cylinder must be less than or equal to 0.75D in each eye. 6. Subjects' ADD power must be in the range of +0.75 to +2.50D in each eye. 7. Subjects' must have the best corrected visual acuity of 20/20-3 or better in each eye. 8. Subjects' should own a wearable pair of spectacles. 9. Subjects' must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration). 10. Subjects' must respond positively to at least on symptom on the Presbyopis Symptoms Questionnaire or already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.).

Exclusion criteria

1. Currently pregnant or lactating (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 systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. 4. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.) 5. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear. 6. Any ocular infection. 7. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 8. History of binocular vision abnormality or strabismus. 9. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV). 10. History of diabetes. 11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Design outcomes

Primary

Measure	Time frame	Description
Binocular Distance Visual Acuity (LogMAR)	8-12 days post wear	Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m\^2. The test was presented under the condition High luminance (250 cd/m\^2) High Contrast (90%)
Binocular Near Visual Acuity (logMAR)	8-12 days post wear	Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast, at 40cm under 250 cd/m\^2. The test was presented under the condition High Luminance (250cd/m\^2) High Contrast (90%).
Percentage of Eyes With Corneal Staining Grade 3 or Higher	8-12 days post wear	Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions.
Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher	8-12 days post wear	The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) using the Efron Grading Scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe. The data was dichotomized into two group subjects with grade 3 or higher Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.
Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher	8-12 days post wear	Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.
CLUE Overall Quality of Vision Using the Contact Lens User Experience (CLUE)TM Questionnaire	8-12 days post wear	CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

Countries

United States

Participant flow

Pre-assignment details

This study enrolled a total of 298 subjects. Subjects were stratified as either Hyperopes or Myopes, which was determined by their sphere power. Of the enrolled subjects 22 did not meet the eligibility criteria and 276 subjects were randomized a study lens. Of the randomized subjects 29 were discontinued and 247 subjects completed the study.

Participants by arm

Arm	Count
Etafilcon A/ Lotrafilcon B Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A and then received the lotrafilcon B.	139
Lotrafilcon B/ Etafilcon A Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B and then received the etafilcon A.	137
Total	276

Withdrawals & dropouts

Period	Reason	FG000	FG001
Period 1	Adverse Event	0	1
Period 1	Lens Power Not Available	0	1
Period 1	No Longer Meets Eligibility criteria	1	0
Period 1	Protocol Violation	4	4
Period 1	Study Site office Closed	0	1
Period 1	Test Article Not Available	4	1
Period 1	Unsatisfactory Visual Response	0	3
Period 2	Lens Discomfort	1	0
Period 2	No longer meets Eligibility Criteria	1	0
Period 2	Protocol Violation	0	2
Period 2	Study Site office Closed	1	1
Period 2	Unsatisfactory lens Fitting	0	1
Period 2	Unsatisfactory Visual Response	1	1

Baseline characteristics

Characteristic	Etafilcon A/ Lotrafilcon B	Lotrafilcon B/ Etafilcon A	Total
Age, Continuous	50.49 years STANDARD_DEVIATION 6.626	50.90 years STANDARD_DEVIATION 6.775	50.69 years STANDARD_DEVIATION 6.691
Race/Ethnicity, Customized American Indian or Alaska Native	2 participants	0 participants	2 participants
Race/Ethnicity, Customized Asian	2 participants	3 participants	5 participants
Race/Ethnicity, Customized Black or African American	13 participants	10 participants	23 participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 participants	1 participants	1 participants
Race/Ethnicity, Customized other	1 participants	0 participants	1 participants
Race/Ethnicity, Customized White	121 participants	123 participants	244 participants
Region of Enrollment United States	139 participants	137 participants	276 participants
Sex: Female, Male Female	108 Participants	108 Participants	216 Participants
Sex: Female, Male Male	31 Participants	29 Participants	60 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 276	0 / 276
serious Total, serious adverse events	0 / 276	0 / 276

Outcome results

Primary

Binocular Distance Visual Acuity (LogMAR)

Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m\^2. The test was presented under the condition High luminance (250 cd/m\^2) High Contrast (90%)