2-week Evaluation of Marketed Silicone Hydrogel Contact Lenses in Indian Population

NCT02394808 | Completed Results

• 1 other identifier: CR-5625
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the clinical performance of two marketed silicone hydrogel contact lenses in an Indian population in the following areas: physiological characteristics, comfort characteristics and vision characteristics.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Subjective Overall Comfort

  Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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.

  11 days Post fit

• Subjective Overall Quality of Vision

  Subjective Overall quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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.

  11 days post fit

Study Arms (2)

Test Lens 1

EXPERIMENTAL

senofilcon A (Approved contact lens material)

Device: senofilcon A; Device: lotrafilcon B

Test Lens 2

ACTIVE COMPARATOR

lotrafilcon B (Approved contact lens material)

Device: senofilcon A; Device: lotrafilcon B

Interventions

senofilcon A DEVICE

One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day

Test Lens 1; Test Lens 2

lotrafilcon B DEVICE

One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day

Test Lens 1; Test Lens 2

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject must read, 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 18 and less than 40 years of age.
• The subject's corrected spherical equivalent distance refraction must be in the range of -1.00 to -5.00D in each eye with visual acuity of 20/25 provided study lenses in each eye.
• The subject must have less than -1.00 D of cylindrical refraction.
• The subject must have best corrected visual acuity of 20/25 or better in each eye.
• The subject must be an adapted soft contact lens wearer in both eyes.
• The subject must have normal eyes.

You may not qualify if:

• Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued)
• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
• Any previous, or planned ocular or interocular surgery (e.g. radial keratotomy, PRK, 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 infections
• 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 the investigational clinic (e.g. investigator, Coordinator, Technician)

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Unknown Facility

Chennai, Tamil Nadu, 600006, India

Location

Results Point of Contact

• Title: Tawnya Wilson O.D. SR. MANAGER GLOBAL CLINICAL SALES EDU
• Organization: Johnson & Johnson Vision Care Inc.

TWilson@ITS.JNJ.com

443-1834

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 20, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 19, 2018
• Results First Posted: June 19, 2017

Record last verified: 2017-03

Locations

IN (1)