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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01844388
First received: April 29, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Contact Lens Lubrication
Drug: carboxymethylcellulose based eye drop formula
Drug: carboxymethylcellulose sodium based eye drop solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    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:
  • Average Daily Contact Wearing Time [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    The average reported number of hours per day that contact lenses were worn by participants during the previous 7 days.

  • Reason for Contact Lens Replacement [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    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.


Enrollment: 365
Study Start Date: April 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844388

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01844388     History of Changes
Other Study ID Numbers: 10077X-001
Study First Received: April 29, 2013
Results First Received: September 25, 2014
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014