OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers

Presbyopia Clinical Trial

Official title:

Clinical Study of OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965820
• Other study ID #: LCO115-P001
• Status: Completed
• Phase: N/A
• Start date: December 16, 2016
• Est. completion date: April 1, 2017

Study information

• Verified date: March 2018
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate OPTI-FREE® PureMoist® (OFPM) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Must sign an informed consent document;

• Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness;

• Near spectacle add of +0.50 or greater;

• Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;

• Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;

• Currently using a non-Alcon multi-purpose solution to care for lenses (at least 2 months);

• Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study;

• Other protocol-specific inclusion criteria may apply.

Exclusion Criteria:

• Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);

• Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator;

• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear;

• Monocular (only 1 eye with functional vision) or fit with only 1 lens;

• Known sensitivity to any ingredients in OFPM;

• Prior refractive surgery;

• History of herpetic keratitis, ocular surgery, or irregular cornea;

• Pathological dry eye that precludes contact lens wear;

• Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;

• Participation in any clinical study within 30 days of Visit 1;

• Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days;

• Other protocol-specific exclusion criteria may apply.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Opti-Free® PureMoist® contact lens solution

• Habitual Multi-Purpose Contact Lens Solution

• Habitual Contact Lenses
Subject's habitual contact lens brand worn in a daily wear modality for 30 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon, a Novartis Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30	CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.	Day 30, each product

External Links

•   Results from the Novartis Clinical Trial Results Website