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N/A N=121 Randomized Double-blind Supportive Care

OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers

Presbyopia

Enrolled (actual)
121
Serious AEs
0.4%
Results posted
Apr 2018
Primary outcome: Primary: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30 — 13.4; 15.8 units on a scale — p==0.0030

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Opti-Free® PureMoist® contact lens solution (Device); Habitual Multi-Purpose Contact Lens Solution (Device); Habitual Contact Lenses (Device)
Age
Adult, Older Adult · 45+ yrs
Sex
All
Sponsor
Alcon, a Novartis Company
Primary completion
Apr 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
13.4; 15.8 =0.0030 sig

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.

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02965820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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