A Clinical Trial to Evaluate Investigational Silicone Hydrogel Contact Lenses Worn Continuously for One Week

Visual Disorder Clinical Trial

Official title:

Echo Ionic Silicone Hydrogel 6-Month Extended Wear Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543528
• Other study ID #: CR-5201
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: November 8, 2016

Study information

• Verified date: September 2019
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group clinical trial design. All subjects will participate in a 2-week daily disposable contact lens adaptation period prior to being randomized into one of the four extended wear lenses. The study has a total of 9 scheduled study visits and a total duration of ~197 days. The lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: November 8, 2016
• Est. primary completion date: November 8, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• The subject must read and understand English and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

• The subject must be at least 18 and no more than 39 years of age.

• The subject's spherical equivalent distance refraction must be in the range of -1.00 to -5.50 diopters in each eye.

• The subject's refractive cylinder must be less than 1.00 diopters in each eye.

• The subject must have best corrected visual acuity of 20/30 or better in each eye.

• The subject must be without history of contact lens use in the past 12 months.

• The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

• Any previous experience wearing contact lenses on an overnight or extended wear basis (at least 1 night per month)

• Currently pregnant or lactating (self reported) (subjects who become pregnant during the study will be discontinued).

• Currently a regular smoker (1 or more times per month).

• Current routine swimmer (1 or more times per month).

• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.

• Any systemic disease (ex. Sjögren's Syndrome), autoimmune disease (ex. rheumatoid arthritis), or use of medication (ex. chronic steroid use), which may interfere with contact lens wear.

• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.

• Any previous or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), etc.).

• 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.

• Any ocular infection.

• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

• Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

• History of binocular vision abnormality or strabismus.

• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self report).

• Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).

Related Conditions & MeSH terms

• Vision Disorders
• Visual Disorder

Intervention

Device:
• Investigational Lens 1
One fresh pair of Investigational Lens 1 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
• Investigational Lens 2
One fresh pair of Investigational Lens 2 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
• Investigational Lens 3
One fresh pair of Investigational Lens 3 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
• etafilcon A (Reusable)
One fresh pair of etafilcon A (Reusable) contact lenses worn continuously in 6nights/7 days wear cycles for 6 months of total wear.
• etafilcon A (1-Day)
2-week contact lens adaptation period wearing prior to randomization

Locations

Country	Name	City	State
India	Medical Research Foundation, Sankara Nethralaya	Chennai

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE)	The number of first serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear (possible, probable or very likely) during a 6-month period (contact lens extended wear period) was assessed via Biomicroscopy. A biomicroscope was used to detect the presence of a corneal infiltrate for each subject eye (Yes: corneal infiltrates detected, No: None present). The number of subjects with corneal infiltrative events was reported for each lens type.	Up to 6 months
Secondary	Overall Comfort Score	Overall comfort was 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). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation.	Time Frame Up to 6 months
Secondary	Overall Vision Score	Overall quality of vision score was 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). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation.	Time Frame Up to 6 months