Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses

Myopia Clinical Trial

Official title:

Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098745
• Other study ID #: EX-MKTG-79
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: April 11, 2017

Study information

• Verified date: April 2019
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.

Description:

This is a 40-subject, double masked, randomized, bilateral, non-dispensing fitting trial comparing hydrogel and silicone hydrogel lens materials. 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 each pair bilaterally in a series of three short fitting comparisons.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 11, 2017
• Est. primary completion date: March 1, 2017
• 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 who is not wearing any of the study lenses.

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

• Has a spectacle cylinder up to 0.75D (Diopter) 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 (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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Omafilcon A
contact lens
• Somofilcon A
contact lens
• Omafilcon A - Proclear (PC)
contact lens

Locations

Country	Name	City	State
Mexico	Optometry Clinic, National Autonomous University	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed.	Baseline (lens insertion), 1 hour
Primary	Comfort	Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)	Insertion, 1hr
Primary	Lens Centration	Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)	Insertion
Primary	Lens Centration	Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)	1 Hour
Primary	Post-blink Lens Movement	Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)	Insertion
Primary	Post-blink Lens Movement	Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)	1 Hour
Primary	Lens Fit Acceptance	Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)	Insertion
Primary	Lens Fit Acceptance	Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)	1 Hour
Primary	Lens Fit Preference	Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))	1 Hour
Primary	Limbal Redness	Redness of limbal area (Scale: 0-4, 0 = none, 4=severe)	1 Hour
Primary	Bulbar Redness	Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)	1 Hour