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OpenTrials
Completed

NCT Number: NCT01844388

A Study to Compare a New Eye Drop Formulation With Refresh Contacts®

This study will compare the safety and efficacy of a new carboxymethylcellulose based eye drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.

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Key information

Conditions

Contact Lens Lubrication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bloomington, Illinois, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

-Adapted contact wearer with daily usage of at least 6 hours a day, 5 days a week.

Exclusion criteria

  • Wearing monovision lenses
  • Have had refractive surgery within the previous 12 months
  • Have infection of the eye, eyelids or eye structures.

Treatment and study plan

carboxymethylcellulose based eye drop formula

Drug

1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.

carboxymethylcellulose sodium based eye drop solution

Drug

1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.

Other names: REFRESH CONTACTS®

Primary outcomes

  1. Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline

    Time frame: Baseline, Day 90

    Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.

Other outcomes

  1. Average Daily Contact Wearing Time

    Time frame: Day 90

    The average reported number of hours per day that contact lenses were worn by participants during the previous 7 days.

  2. Reason for Contact Lens Replacement

    Time frame: Day 90

    The reason the contact lens needed to be replaced was recorded for each eye. The following categories are reported: Scheduled Replacement, Discomfort, Lens Damage, Unacceptable Vision and Lens Lost. There may be multiple reasons for replacement of the contact lens for a single eye.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 1, 2013
Registry last updated
Apr 16, 2019

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.