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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02847169
Other study ID # EX-MKTG-66
Secondary ID
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


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
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