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

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ClinicalTrials.gov Identifier: NCT01844388
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : September 29, 2014
Last Update Posted : September 29, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contact Lens Lubrication Drug: carboxymethylcellulose based eye drop formula Drug: carboxymethylcellulose sodium based eye drop solution Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Carboxymethylcellulose Based Eye Drop Formula
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.
Drug: carboxymethylcellulose based eye drop formula
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.

Active Comparator: REFRESH CONTACTS®
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.
Drug: carboxymethylcellulose sodium based eye drop solution
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 Name: REFRESH CONTACTS®




Primary Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844388


Locations
United States, Illinois
Bloomington, Illinois, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01844388     History of Changes
Other Study ID Numbers: 10077X-001
First Posted: May 1, 2013    Key Record Dates
Results First Posted: September 29, 2014
Last Update Posted: September 29, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Tetrahydrozoline
Pharmaceutical Solutions
Ophthalmic Solutions
Carboxymethylcellulose Sodium
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Laxatives
Gastrointestinal Agents