OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers

• ClinicalTrials.gov Identifier: NCT02965820
• Recruitment Status: Completed
• First Posted: November 17, 2016
• Results First Posted: April 26, 2018
• Last Update Posted: July 12, 2018
• Sponsor: Alcon, a Novartis Company
• Information provided by (Responsible Party): Alcon Research ( Alcon, a Novartis Company )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Presbyopia	Device: Opti-Free® PureMoist® contact lens solution; Device: Habitual Multi-Purpose Contact Lens Solution; Device: Habitual Contact Lenses	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Clinical Study of OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
• Actual Study Start Date: December 16, 2016
• Actual Primary Completion Date: April 1, 2017
• Actual Study Completion Date: April 1, 2017

Arms and Interventions

Arm	Intervention/treatment
OFPM, then HMPS; 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; Other Name: OPTI-FREE® PureMoist®; Device: Habitual Multi-Purpose Contact Lens Solution; Device: Habitual Contact Lenses; Subject's habitual contact lens brand worn in a daily wear modality for 30 days.
HMPS, then OFPM; 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; Other Name: OPTI-FREE® PureMoist®; Device: Habitual Multi-Purpose Contact Lens Solution; Device: Habitual Contact Lenses; Subject's habitual contact lens brand worn in a daily wear modality for 30 days.

Outcome Measures

Primary Outcome Measures :

1. Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30 [ Time Frame: Day 30, each product ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Alcon, a Novartis Company

Investigators

• Study Director: Clinical Project Manager, CPM; Alcon, A Novartis Division

  Study Documents (Full-Text)

Documents provided by Alcon Research ( Alcon, a Novartis Company ):

Study Protocol  [PDF] January 3, 2017

Statistical Analysis Plan  [PDF] December 11, 2016

More Information

• Responsible Party: Alcon, a Novartis Company
• ClinicalTrials.gov Identifier: NCT02965820
• Other Study ID Numbers: LCO115-P001
• First Posted: November 17, 2016
• Results First Posted: April 26, 2018
• Last Update Posted: July 12, 2018
• Last Verified: March 2018

Keywords provided by Alcon Research ( Alcon, a Novartis Company ):

Contact lens induced dryness

Additional relevant MeSH terms:

Presbyopia; Refractive Errors; Eye Diseases; Contact Lens Solutions; Pharmaceutical Solutions; Disinfectants; Anti-Infective Agents