Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.

Myopia Clinical Trial

Official title:

Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727816
• Other study ID #: EX-MKTG-65
• Status: Completed
• Phase: N/A
• First received: March 30, 2016
• Last updated: July 20, 2017
• Start date: April 2016
• Est. completion date: August 2016

Study information

• Verified date: July 2017
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.

Description:

This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different hydrogel lens materials. For each study, this study will involve 2 visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be randomized to wear the test and control lenses, in the right or left eye, in a series of four short fitting comparisons as follows:

Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D

Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D

Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D

Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

• 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 (Contact Lens) wearer.

• Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)

• Has a spectacle cylinder up to 0.75D (Diopters) 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:

A person will be excluded from the study if he/she:

• 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 - 6.00D

• 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 (GPC) 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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• filcon IV I (BC 8.6)
control lens
• filcon IV I (BC 8.7)
control lens
• ocufilcon D
test lens
• methafilcon A (BC 8.6)
control lens
• methafilcon A (BC 8.7)
control lens
• somofilcon A
test lens

Locations

Country	Name	City	State
Mexico	Optometry Clinic, National Autonomous University	Mexico D.F.

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Centration - Pair One	Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).	Baseline and 1 hour
Primary	Centration - Pair Two	Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable).	Baseline and 1 hour
Primary	Centration - Pair Three	Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable).	Baseline and 1 hour
Primary	Centration - Pair Four	Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).	Baseline and 1 hour
Primary	Post-blink Movement - Pair One	Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	Baseline
Primary	Post-blink Movement - Pair One	Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	1 hour
Primary	Post-blink Movement - Pair Two	Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	Baseline
Primary	Post-blink Movement - Pair Two	Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	1 hour
Primary	Post-blink Movement - Pair Three	Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	Baseline
Primary	Post-blink Movement - Pair Three	Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	1 hour
Primary	Post-blink Movement - Pair Four	Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	Baseline
Primary	Post-blink Movement - Pair Four	Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	1 hour
Primary	Lens Tightness - Pair One	Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)	Baseline and 1 hour
Primary	Lens Tightness - Pair Two	Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)	Baseline and 1 hour
Primary	Lens Tightness - Pair Three	Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)	Baseline and 1 hour
Primary	Lens Tightness - Pair Four	Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)	Baseline and 1 hour
Primary	Overall Fit Preference - Pair One	Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference.	Baseline and 1 hour
Primary	Overall Fit Acceptance - Pair Two	Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference.	Baseline and 1 hour
Primary	Overall Fit Acceptance - Pair Three	Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference.	Baseline and 1 hour
Primary	Overall Fit Acceptance - Pair Four	Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference.	Baseline and 1 hour