Clinical Performance of Stenfilcon A Versus Filcon II 3

Myopia Clinical Trial

Official title:

Clinical Performance of Stenfilcon A Versus Filcon II 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808209
• Other study ID #: EX-MKTG-40
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: May 2013

Study information

• Verified date: July 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical Performance of Stenfilcon vs. Filcon II 3

Description:

The objective of this study is to compare the comfort and clinical performance of Stenfilcon vs. Filcon II 3 compared to subject's habitual contact lenses. The null hypothesis is that there is no difference in the clinical performance between the two sets of lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects must satisfy the following conditions prior to inclusion in the study:

• Based on his/her knowledge, must be in good general health. Be of legal age (18 years) or older.

• Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.

• Read, indicate understanding of, and sign Written Informed Consent (Appendix 1)

• Require a contact lens prescription between -0.50 and -6.00 and have no more than -.75dioptor (D) of astigmatism in both eyes

• Achieve visual acuity of 6/9 or better in each eye with a spherical contact lens prescription.

• An existing soft contact lens wearer of any modality.

• Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so.

• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

• No amblyopia.

• No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes).

• No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings greater than Grade 2: corneal edema, tarsal abnormalities, and conjunctival injection).

• No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology.)

• No aphakia

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

• Neophytes, who have not worn lenses before

• Greater than 0.75D of refractive astigmatism in either eye

• Presence of clinically significant (grade 3 or above) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.

• Presence of ocular or systemic disease or need of medication 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 the limbus

• Giant papillary conjunctivitis (GPC) Grade 3 or above

• Anterior uveitis or iritis (past or present)

• Seborrheic eczema, seborrheic conjunctivitis

• History of corneal ulcer or fungal infections

• Poor personal hygiene

• A known history of corneal hypoesthesia (reduced corneal sensitivity).

• Contact lens best corrected Snellen visual acuities (VA) worse than 6/9

• Aphakia, Keratoconus or a highly irregular cornea

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• stenfilcon A
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
• filcon II 3
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Locations

Country	Name	City	State
United Kingdom	University of Aston	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily and Comfortable Wearing Time	Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)	Baseline
Primary	Daily and Comfortable Wearing Time	Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.)	1 week
Primary	Handling	Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily).	1 Week
Primary	Comfort	Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all)	Baseline
Primary	Comfort	Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).	1 Week
Primary	Dryness	Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all)	Baseline
Primary	Dryness	Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).	1 Week
Primary	Vision Quality	Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)	Baseline
Primary	Vision Quality	Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)	1 Week
Primary	Eye Whiteness	Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).	Baseline
Primary	Eye Whiteness	Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).	1 Week
Primary	Overall Satisfaction	Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).	Baseline
Primary	Overall Satisfaction	Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).	1 Week
Primary	Visual Acuity logMAR	Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR.	Baseline
Primary	Visual Acuity logMAR	Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR.	Dispense
Primary	Visual Acuity logMAR	Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR	1 Week
Primary	Wettability	Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.	1 Week
Secondary	Blood Vessel Coverage	Assessment of ocular health. Collected at baseline after removal of lenses. Percent of blood vessel coverage.	Baseline
Secondary	Blood Vessel Coverage	Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of blood vessel coverage.	1 Week
Secondary	Conjunctival Redness	Assessment of ocular health. Collected at baseline after removal of lenses. Percentage of conjunctival redness.	Baseline
Secondary	Conjunctival Redness	Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of conjunctival redness.	1 Week
Secondary	Corneal Staining	Assessment of ocular health. Collected at baseline after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )	Baseline
Secondary	Corneal Staining	Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )	1 Week
Secondary	Conjunctival Staining	Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )	1 Week