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A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery

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ClinicalTrials.gov Identifier: NCT01886690
Recruitment Status : Completed
First Posted : June 26, 2013
Results First Posted : October 5, 2015
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.

Condition or disease Intervention/treatment Phase
Bilateral LASIK Surgery Drug: carboxymethylcellulose sodium based new eye drop formulation Drug: carboxymethylcellulose sodium based eye drops Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : August 20, 2013
Actual Primary Completion Date : August 18, 2014
Actual Study Completion Date : August 18, 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: New Eye Drop Formulation
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
 Drug: carboxymethylcellulose sodium based new eye drop formulation
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
Active Comparator: REFRESH PLUS®
1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
 Drug: carboxymethylcellulose sodium based eye drops
1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Other Name: REFRESH PLUS®


Outcome Measures
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Primary Outcome Measures :
  1. Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale [ Time Frame: Day 90 ]
    The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability).


Secondary Outcome Measures :
  1. Change From Baseline in Corneal Staining in the Worse Eye [ Time Frame: Baseline, Day 90 ]
    The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining in the worse eye following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement) and a positive change from baseline represents an increase in corneal staining (worsening).

  2. Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye [ Time Frame: Baseline, Day 90 ]
    TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).

  3. Change From Baseline in the Schirmer Test in the Worse Eye [ Time Frame: Baseline, Day 90 ]
    The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes in the worse eye. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).

  4. Change From Baseline in Uncorrected Visual Acuity in the Worse Eye [ Time Frame: Baseline, Day 90 ]
    Uncorrected visual acuity in the worse eye is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) without corrective lenses. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline in the number of letters read correctly indicates an improvement and a negative number change from baseline indicates a worsening.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-Patients scheduled for LASIK surgery in both eyes.

Exclusion Criteria:

  • Any systemic medication use within 3 months of screening (including over the counter, herbal, prescription, or nutritional supplement) which may affect dry eye or vision
  • Use of topical eye medication other than prescribed for use in pre- or post-operative care
  • Use of RESTASIS® or other topical ophthalmic cyclosporine product within 6 months prior to Screening
  • Eye infection, inflammation, or allergy
  • Soft contact lenses in the previous 7 days or rigid contact lenses in the previous 30 days prior to LASIK surgery.
Contacts and Locations
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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): NCT01886690


Locations
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Australia
New South Wales, Australia
Canada, British Columbia
Kelowna, British Columbia, Canada
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01886690    
Other Study ID Numbers: 11002X-002
First Posted: June 26, 2013    Key Record Dates
Results First Posted: October 5, 2015
Last Update Posted: April 16, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Carboxymethylcellulose Sodium
Ophthalmic Solutions
Pharmaceutical Solutions
Laxatives
Gastrointestinal Agents