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OpenTrials
Completed

NCT Number: NCT02965820

OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers

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.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Opti-Free® PureMoist® contact lens solution

Device

Other names: OPTI-FREE® PureMoist®

Habitual Multi-Purpose Contact Lens Solution

Device

Habitual Contact Lenses

Device

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon, a Novartis Company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2016
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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