Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses

Myopia Clinical Trial

Official title:

Non-Dispensing Fitting Study Comparing the Clinical Performance of Hydrogel vs. Silicone Hydrogel Sphere Design Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131402
• Other study ID #: EX-MKTG-47
• Status: Completed
• Phase: Phase 4
• First received: April 28, 2014
• Last updated: February 9, 2015
• Start date: May 2014
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this non-dispensing fitting study is to evaluate the subjective comfort, lens handling, lens fitting characteristics and visual acuity of different hydrogel lens designs versus silicone hydrogel lenses

Description:

This is a 60-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different lens materials (hydrogel vs silicone hydrogel). It is anticipated that this study will involve 2 visits, for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear the test and control lenses in a series of three short fitting comparisons.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Is between 18 and 40 years of age (inclusive)

• Has had a self-reported visual exam in the last two years

• Is an adapted soft CL wearer

• Has a CL (Contact Lens) spherical prescription between - 1.00 and - 10.00 (inclusive)

• Has a spectacle cylinder up to 0.75D in each eye.

• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.

• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.

• Has clear corneas and no active ocular disease

• Has read, understood and signed the information consent letter

• Patient contact lens refraction should fit within the available parameters of the study lenses

• Is willing to comply with the wear schedule

• Is willing to comply with the visit schedule

Exclusion Criteria:

• Has never worn contact lenses before.

• Currently wears rigid gas permeable contact lenses.

• Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)

• Has a CL prescription outside the range of - 1.00 to -10.00D

• Has a spectacle cylinder =1.00D of cylinder in either eye.

• Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.

• Presence of clinically significant (grade 2-4) anterior segment abnormalities.

• Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.

• Slit lamp findings that would contraindicate contact lens wear such as:

• Pathological dry eye or associated findings

• Pterygium, pinguecula, or corneal scars within the visual axis

• Neovascularization > 0.75 mm in from of the limbus

• Giant papillary conjunctivitis (GCP) worse than grade 1

• Anterior uveitis or iritis (past or present)

• Seborrheic eczema, Seborrheic conjunctivitis

• History of corneal ulcers or fungal infections

• Poor personal hygiene

• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

• Has aphakia, keratoconus or a highly irregular cornea.

• Has Presbyopia or has dependence on spectacles for near work over the contact lenses.

• Has undergone corneal refractive surgery.

• Is participating in any other type of eye related clinical or research study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• ocufilcon D
Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye.
• omafilcon A
Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye.
• methafilcon A
Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye.

Locations

Country	Name	City	State
Spain	Optometry Research Group (GIO) Optics Department, University of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant's subjective rating for lens handling - insertion and removal	Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #1 (1 hour). Rated by questionnaires (0-100, 100= very easy).	1 hour	No
Primary	Participant's subjective rating for lens comfort - insertion	Surveyed after insertion of each lens for Pair #1 (baseline visit). Rated by questionnaires (0-100, 100= can't feel).	Baseline	No
Primary	Participant's subjective rating for lens comfort - 1 hour post settling	Surveyed after 1 hour post settling of Pair #1 (1 hour). Rated by questionnaires (0-100, 100= can't feel).	1 hour	No
Primary	Participant's subjective rating for lens comfort - stinging/burning	Surveyed after insertion of each lens for Pair #1 (baseline visit). Rated by questionnaires (0-100, 100= extreme stinging).	Baseline	No
Primary	Participant's subjective rating for lens comfort preference	Surveyed after 1 hour of lens wear for each lens for Pair #1 (1 hour). Rated by questionnaires (0-100, 100= very easy).	1 hour	No
Primary	Eye Care Practitioner's objective assessment of Binocular High Contrast Distance Visual Acuity	Assessed after OU insertion of each study lens, prior to dispensing contralateral pairs. Enfilcon A followed by omafilcon A (baseline visit). (Snellen or logMAR Visual Acuity (VA) to nearest letter)	Baseline	No
Primary	Eye Care Practitioner's subjective rating of lens fit preference for right or left lens	Surveyed after 1 hour of lens wear for each lens for Pair #1 (1 hour). Rated by questionnaire (4 possible ratings: Strong right, Slight right, No preference, Slight left, Strong left).	1 hour	No
Primary	Eye Care Practitioner's objective assessment of lens fit, post-blink movement, and primary gaze lag	Assessed after 1 hour of lens wear, for each lens for Pair #1 (1 hour) immediately after the blink - lower lid to be depressed only if necessary for observation. Slit lamp (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)	1 hour	No
Primary	Eye Care Practitioner's objective assessment of lens fit, tightness Push-up Test	Assessed after 1 hour of lens wear, for each lens for Pair #1 (1 hour) Slit lamp. Digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)	1 hour	No
Primary	Eye Care Practitioner's objective assessment of lens fit, centration	Assessed after 1 hour of lens wear, for each lens for Pair #1 (1 hour). Slit Lamp. Lens centration will be recorded in the primary position. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)	1 hour	No
Primary	Participant's subjective rating for lens handling - insertion and removal	Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2 (2 hours). Rated by questionnaires (0-100, 100= very easy).	2 hours	No
Primary	Participant's subjective rating for lens handling - insertion and removal	Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #3 (3 hours). Rated by questionnaires (0-100, 100= very easy).	3 hours	No
Primary	Participant's subjective rating for lens comfort - insertion	Surveyed after insertion of each lens for Pair #2 (1 hour). Rated by questionnaires (0-100, 100= can't feel).	1 hour	No
Primary	Participant's subjective rating for lens comfort - insertion	Surveyed after insertion of each lens for Pair #3 (2 hours). Rated by questionnaires (0-100, 100= can't feel).	2 hours	No
Primary	Participant's subjective rating for lens comfort - 1 hour post settling	Surveyed after 1 hour post settling of Pair #2 (2 hours). Rated by questionnaires (0-100, 100= can't feel).	2 hours	No
Primary	Participant's subjective rating for lens comfort - 1 hour post settling	Surveyed after 1 hour post settling of Pair #3 (3 hours). Rated by questionnaires (0-100, 100= can't feel).	3 hours	No
Primary	Participant's subjective rating for lens comfort - stinging/burning	Surveyed after insertion of each lens for Pair #2 (1 hour). Rated by questionnaires (0-100, 100= extreme stinging).	1 hour	No
Primary	Participant's subjective rating for lens comfort - stinging/burning	Surveyed after insertion of each lens for Pair #3 (2 hours). Rated by questionnaires (0-100, 100= extreme stinging).	2 hours	No
Primary	Participant's subjective rating for lens comfort preference	Surveyed after 1 hour of lens wear for each lens for Pair #2 (2 hours). Rated by questionnaires (0-100, 100= very easy).	2 hours	No
Primary	Participant's subjective rating for lens comfort preference	Surveyed after 1 hour of lens wear for each lens for Pair #3 (3 hours). Rated by questionnaires (0-100, 100= very easy).	3 hours	No
Primary	Eye Care Practitioner's objective assessment of Binocular High Contrast Distance Visual Acuity	Assessed after OU insertion of each study lens, prior to dispensing contralateral pairs. Enfilcon A followed by ocufilcon D (Pair #2 dispense visit at 1 hour). (Snellen or logMAR Visual Acuity (VA) to nearest letter)	1 hour	No
Primary	Eye Care Practitioner's objective assessment of Binocular High Contrast Distance Visual Acuity	Assessed after OU insertion of each study lens, prior to dispensing contralateral pairs. Enfilcon A followed by methafilcon A (Pair #3 dispense visit at 2 hours). (Snellen or logMAR Visual Acuity (VA) to nearest letter)	2 hours	No
Primary	Eye Care Practitioner's subjective rating of lens fit preference for right or left lens	Surveyed after 1 hour of lens wear for each lens for Pair #2 (2 hours). Rated by questionnaire (4 possible ratings: Strong right, Slight right, No preference, Slight left, Strong left).	2 hours	No
Primary	Eye Care Practitioner's subjective rating of lens fit preference for right or left lens	Surveyed after 1 hour of lens wear for each lens for Pair #3 (3 hours). Rated by questionnaire (4 possible ratings: Strong right, Slight right, No preference, Slight left, Strong left).	3 hours	No
Primary	Eye Care Practitioner's objective assessment of lens fit, post-blink movement, and primary gaze lag	Assessed after 1 hour of lens wear, for each lens for Pair #2 (2 hours) immediately after the blink - lower lid to be depressed only if necessary for observation. Slit lamp (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)	2 hours	No
Primary	Eye Care Practitioner's objective assessment of lens fit, post-blink movement, and primary gaze lag	Assessed after 1 hour of lens wear, for each lens for Pair #3 (3 hours) immediately after the blink - lower lid to be depressed only if necessary for observation. Slit lamp (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)	3 hours	No
Primary	Eye Care Practitioner's objective assessment of lens fit, tightness Push-up Test	Assessed after 1 hour of lens wear, for each lens for Pair #2 (2 hours) Slit lamp. Digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)	2 hours	No
Primary	Eye Care Practitioner's objective assessment of lens fit, tightness Push-up Test	Assessed after 1 hour of lens wear, for each lens for Pair #3 (3 hours) Slit lamp. Digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)	3 hours	No
Primary	Eye Care Practitioner's objective assessment of lens fit, centration	Assessed after 1 hour of lens wear, for each lens for Pair #2 (2 hours). Slit Lamp. Lens centration will be recorded in the primary position. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)	2 hours	No
Primary	Eye Care Practitioner's objective assessment of lens fit, centration	Assessed after 1 hour of lens wear, for each lens for Pair #3 (3 hours). Slit Lamp. Lens centration will be recorded in the primary position. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)	3 hours	No
Secondary	Eye Care Practitioner's objective assessment of anterior ocular health, limbal and bulbar hyperemia	Assessed prior to study lens pairs insertions for change from baseline measured at pair #1 (baseline visit), pair #2 (1 hour), pair #3 (2 hours). Slit lamp with white light, low-medium magnification. Brien Holden Vision Institute grading scales for reference, ½ grades recorded. (0-4, 0=none: no injection present, 1= very slight, 2= slight, 3= moderate, 4=severe)	Baseline, 1 hour, 2 hours	No
Secondary	Eye Care Practitioner's objective assessment of anterior ocular health, lower palpebral hyperemia	Assessed prior to study lens pairs insertions for change from baseline measured at pair #1 (baseline visit), pair #2 (1 hour), pair #3 (2 hours). Slit lamp with white light, low-medium magnification. Brien Holden Vision Institute grading scales for reference, ½ grades recorded. (0-4, 0=none: no injection present, 1= very slight, 2= slight, 3= moderate, 4=severe)	Baseline, 1 hour, 2 hours	No
Secondary	Eye Care Practitioner's objective assessment of anterior ocular health, corneal staining	Assessed prior to study lens pairs insertions for change from baseline measured at pair #1 (baseline visit), pair #2 (1 hour), pair #3 (2 hours). Slit lamp with blue light, yellow filter and low-medium magnification. Brien Holden Vision Institute grading scales for reference, ½ grades recorded. (0-4, 0=none, 1= very slight, 2= slight, 3= moderate, 4=severe)	Baseline, 1 hour, 2 hours	No