A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.

Dry Eye Syndromes Clinical Trial

Official title:

A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of the OM3 Tear Formulation With REFRESH OPTIVE® ADVANCED Unit Dose for 3 Months in Patients With Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553772
• Other study ID #: 11182X-001
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2015
• Last updated: October 18, 2017
• Start date: January 6, 2016
• Est. completion date: September 9, 2016

Study information

• Verified date: October 2017
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: September 9, 2016
• Est. primary completion date: September 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Used artificial tears for dry eye

• Visual acuity of at least 20/32 (while wearing glasses, if necessary).

Exclusion Criteria:

• Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study

• Herpes keratitis in the last 6 months

• Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Carboxymethylcellulose Based Eye Drop
Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
• Carboxymethylcellulose Sodium 0.5%
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

Locations

Country	Name	City	State
Australia	Department of Optometry & Vision Sciences, The University of Melbourne	Parkville
Australia	Prof. M.T. Coroneo Pty. Ltd.	Randwick
Australia	The University of New South Wales School of Optometry and Vision Science	Sydney
United States	Texan Eye	Austin	Texas
United States	The Private Practice of Milton Hom, OD	Azusa	California
United States	Havana Research Institute LLC	Burbank	California
United States	Charlotte Eye Ear Nose	Charlotte	North Carolina
United States	Scott and Christie and Associate	Cranberry Township	Pennsylvania
United States	Lugene Eye Institute	Glendale	California
United States	Moyes Eye Center, PC	Kansas City	Missouri
United States	Rochester Ophthalmological Group, PC	Rochester	New York
United States	Ophthalmology Associates	Saint Louis	Missouri
United States	Eric M. White, OD, INC	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score	The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.	Baseline, Day 90
Secondary	Change From Baseline in Tear Break-up Time (TBUT)	TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is used for the calculations and is defined as the eye with the shortest average TBUT at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening.	Baseline, Day 90
Secondary	Change From Baseline in Corneal Staining Score	Total corneal staining with fluorescein was measured in the worse eye using a 6-point scale where 0= none, no staining (best) to 5=severe staining (worst). The total score is calculated as the sum of 5 regions of the cornea, resulting in a possible minimum score of 0 and a maximum possible score of 25 (severe staining score of 5 in all 5 regions). The worse eye is defined as the eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).	Baseline, Day 90
Secondary	Change From Baseline in Conjunctival Staining Score	Total conjunctival staining with lissamine green was measured in the worse eye using a 6-point scale where 0= none (best), no staining to 5=severe staining (worst). The total score is calculated as the sum of the 6 regions of the conjunctiva, resulting in a minimum possible score of 0 maximum possible score of 30 (severe staining score of 5 in 6 regions). The worse eye is defined as eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).	Baseline, Day 90
Secondary	Change From Baseline in the Schirmer Test	The Schirmer Test measures tears produced by the eye over 5 minutes using a paper strip inserted into the eye. The results indicate the presence of dry eye (Normal = greater than 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye defined as the eye with the lowest score at baseline is used to calculate the change at Day 90. A positive number change from baseline indicates an increase in tears (improvement).	Baseline, Day 90

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