Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

Astigmatism Clinical Trial

Official title:

Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356692
• Other study ID #: EX-MKTG-38-MTF
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: May 2012

Study information

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

Clinical Trial Summary

The purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.

Description:

This was a non-dispensing, single-masked, randomized, contralateral study comparing Enfilcon A (test) against Senofilcon A (control). Each subject was randomized to wear the test lens in one eye and the control lens in the other eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

1. Based on his/her knowledge, must be in good general health.

2. Be 18 to 38 years old.

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

4. Read, indicate understanding of, and sign Written Informed Consent.

5. Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (Avaira or Oasys) being evaluated in this trial.

6. Require a visual correction in both eyes.

7. Require a prescription between +8.00D and -12.00D and have less than or equal to 0.75D of astigmatism in both eyes.

8. Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.

9. 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).

• lamp findings Grade 2 or above: 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:

1. 0.75D or greater of refractive astigmatism in either eye.

2. Presbyopic or current monovision contact lens wear.

3. Cannot be currently wearing either lenses (Avaira or Oasys).

4. Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures.

5. Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.

6. 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) worse than Grade 1

• 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)

7. Contact Lens best corrected Snellen visual acuities (VA) worse than 20/30.

8. Aphakia, Keratoconus or a highly irregular cornea.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• enfilcon A
Test lens
• senofilcon A
Control lens

Locations

Country	Name	City	State
United States	Schaeffer Eye Associates	Birmingham	Alabama
United States	Beaches Family Eyecare	Jacksonville	Florida
United States	Todays Eyecare, LLC	Lafayette	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort at Insertion	Participant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline.	Baseline
Primary	Comfort at Insertion	Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes.	15 minutes
Primary	Comfort Preference	Participant's response for comfort preference of enfilcon A (test) lens, senofilcon A(control) lens at insertion.	Baseline
Primary	Comfort Preference	Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear.	15 minutes