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OpenTrials
Completed

NCT Number: NCT02066922

A Comparative Study of Two Daily Disposable Contact Lenses in Higher Myopia Subjects

The purpose of this study is to compare the change from baseline in central corneal curvature at one week, between 2 silicone hydrogel lenses, in higher myopic subjects.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Participants were expected to attend 4 office visits. Visit 1 was the Screening/Enrollment visit. At Visit 2 (Baseline Visit), participants were randomized and the study lenses were trial fit. At Visit 3 (Dispense Visit), participants received study lenses for approximately 1 week of wear. Visit 4 was the Exit visit. Expected duration of participation in the study was 3 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sign Informed Consent document;
  • Higher degree of myopia in both eyes, i.e. habitual contact lens power between -10.00 diopters (D) and -17.00D;
  • Best corrected distance visual acuity greater than or equal to 20/30 in each eye (measured with either spectacle refraction or habitual contact lenses plus over refraction);
  • Manifest astigmatism less than or equal to -1.00D;
  • Soft contact lens wear in both eyes at least 5 days per week and at least 8 hours per day;
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Pregnant or lactating;
  • Eye injury or surgery within twelve weeks immediately prior to enrollment;
  • Any ocular condition that contraindicates contact lens wear;
  • History of herpetic keratitis;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including any use of topical ocular medications that would require instillation during contact lens wear, except for approved lubricating drops;
  • Clinical significant dry eye not responding to treatment;
  • Previous corneal or refractive surgery or irregular cornea;
  • Requires reading glasses;
  • Participation in a clinical trial (including contact lens or contact lens care product) within the previous 30 days;
  • Wears habitual lenses in an extended wear modality (routinely sleeps in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

delefilcon A contact lens

Device

Commercially available silicone hydrogel contact lens

Other names: DAILIES® TOTAL1®

Narafilcon A contact lens

Device

Commercially available silicone hydrogel contact lens

Other names: 1-DAY ACUVUE TRUEYE™

Spectacles

Device

Incremental prescription worn over contact lenses if needed to provide acceptable vision

Primary outcomes

  1. Change in Average Central Corneal Curvature From Dispense at Week 1

    Time frame: Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)

    Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.

Secondary outcomes

  1. Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1

    Time frame: Baseline, Week 1 (Day 8 of lens wear)

    Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject's current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 20, 2014
Registry last updated
Jun 8, 2015

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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