Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear

Astigmatism Clinical Trial

Official title:

Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847169
• Other study ID #: EX-MKTG-66
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: December 13, 2016
• Start date: September 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric and ocufilcon D toric contact lenses after 1 week of wear in each pair.

Description:

This is a 30-subject, prospective, randomized, double masked, bilateral, 1 week cross-over study comparing the fitting characteristics of filcon IV1 toric lenses against ocufilcon D hydrogel toric lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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 toric contact lens wearer

• Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)

• Have no less than -0.75D of astigmatism and no more than -2.00 D in both eyes.

• 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 (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).

• Is willing to comply with the visit schedule

Exclusion Criteria:

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

• Has a CL prescription outside the range of the available parameters of the study lenses.

• Has a spectacle cylinder less than -0.75D or more than -2.00 D of cylinder in either eye.

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

• 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. Confidential EX-MKTG-66 Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear 10

• 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: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• filcon IV1
contact lens
• ocufilcon D
contact 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	Overall fit acceptance	Investigator's preference for lens fit acceptance for filcon IV1 and ocufilcon D. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect	Up to 1 week	No
Primary	Lens centration	Lens centration for filcon IV1 and ocufilcon D. (Centered - optimal, decentered slightly, or substantially decentered).	Up to 1 week	No
Primary	Post-blink movement	Post-blink movement for filcon IV1 and ocufilcon D. Scale 0-4, 0=insufficient, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement.	Up to 1 week	No
Primary	Overall stability	Overall lens stability for falcon IV1 and ocufilcon D. Scale 0-4, 0=very poor, 4=excellent	Up to 1 week	No
Primary	Corneal coverage	Corneal coverage for filcon IV1 and ocufilcon D. (yes or no)	Up to 1 week	No
Primary	Lens orientation in primary position of gaze	Lens orientation in primary position of gaze for filcon IV1 and ocufilcon D by slit lamp.	Up to 1 week	No
Primary	Rotational recovery in degrees after 60 seconds	Rotational recovery in degrees after 60 seconds for filcon IV1 and ocufilcon D by slit lamp.	Up to 1 week	No