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

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

Study Overview

• Status: Completed
• Conditions: Bilateral LASIK Surgery
• Intervention / Treatment: Drug: carboxymethylcellulose sodium based new eye drop formulation; Drug: carboxymethylcellulose sodium based eye drops

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales, Australia
• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: REFRESH PLUS®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale	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).	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Corneal Staining in the Worse Eye	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).	Baseline, Day 90
Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye	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).	Baseline, Day 90
Change From Baseline in the Schirmer Test in the Worse Eye	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).	Baseline, Day 90
Change From Baseline in Uncorrected Visual Acuity in the Worse Eye	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.	Baseline, Day 90

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• Wallerstein A, Jackson WB, Chambers J, Moezzi AM, Lin H, Simmons PA. Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose. Clin Ophthalmol. 2018 May 7;12:839-848. doi: 10.2147/OPTH.S163744. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2013
• Primary Completion (ACTUAL): August 18, 2014
• Study Completion (ACTUAL): August 18, 2014

Study Registration Dates

• First Submitted: June 24, 2013
• First Submitted That Met QC Criteria: June 25, 2013
• First Posted (ESTIMATE): June 26, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Pharmaceutical Solutions; Laxatives; Ophthalmic Solutions; Carboxymethylcellulose Sodium
• Other Study ID Numbers: 11002X-002