OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers

NCT02965820 | Completed Results

• 1 other identifier: LCO115-P001
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Presbyopia

Keywords

Contact lens induced dryness

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

OFPM, then HMPS

OTHER

OPTI-FREE® PureMoist® multi-purpose contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.

Device: Opti-Free® PureMoist® contact lens solution; Device: Habitual Multi-Purpose Contact Lens Solution; Device: Habitual Contact Lenses

HMPS, then OFPM

OTHER

Subject's habitual multi-purpose contact lens solution in Period1, followed by OPTI-FREE® PureMoist® contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.

Device: Opti-Free® PureMoist® contact lens solution; Device: Habitual Multi-Purpose Contact Lens Solution; Device: Habitual Contact Lenses

Interventions

Opti-Free® PureMoist® contact lens solution DEVICE

Also known as: OPTI-FREE® PureMoist®

HMPS, then OFPM; OFPM, then HMPS

Habitual Multi-Purpose Contact Lens Solution DEVICE

HMPS, then OFPM; OFPM, then HMPS

Habitual Contact Lenses DEVICE

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

HMPS, then OFPM; OFPM, then HMPS

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon, a Novartis Company: lead

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Head, CDMA Vision Care Franchise
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Project Manager, CPM

  Alcon, A Novartis Division

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 17, 2016
• Study Start: December 16, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 12, 2018
• Results First Posted: April 26, 2018

Record last verified: 2018-03