Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease

Phase 3

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Carboxymethylcellulose Based Eye Drop Formulation A; Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops; Drug: Carboxymethylcellulose Based Lubricant Eye Drops; Drug: Carboxymethylcellulose Based Eye Drop Formulation B

• Registration Number: NCT01459588
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-01
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-25
• Primary Completion: 2012-02-15
• Study Completion: 2012-02-15
• Results First Submitted: 2013-02-11
• Results First Submitted QC: 2013-02-11
• Results First Posted: 2013-03-14
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

• Dry eyes
• Current use of eye drops for dry eye at least twice daily, on average for at least 3 months

Exclusion Criteria

• Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months
• Need to wear contact lenses during the study, or has worn contact lenses in the last 6 months
• Active ocular allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carboxymethylcellulose Based Eye Drop Formulation A	Carboxymethylcellulose Based Eye Drop Formulation A	Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
Carboxymethylcellulose Preservative-Free Lubricant Eye Drops	Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops	Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Carboxymethylcellulose Based Lubricant Eye Drops	Carboxymethylcellulose Based Lubricant Eye Drops	Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
Carboxymethylcellulose Based Eye Drop Formulation B	Carboxymethylcellulose Based Eye Drop Formulation B	Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Ocular Surface Disease Index© Questionnaire Score	Baseline, Day 30	The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Tear Break-up Time	Baseline, Day 30	Tear Break-up Time (TBUT) was assessed at Baseline and Day 30. TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The shorter the tear break-up time, the worse the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive change from baseline indicates improvement.
Change From Baseline in Corneal Staining	Baseline, Day 30	The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining 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 a maximum score of 25. The higher the grade score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in corneal staining (improvement).
Change From Baseline in Conjunctival Staining	Baseline, Day 30	The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).
Change From Baseline in Schirmer Test Results	Baseline, Day 30	The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. 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. The worse eye at baseline is used to calculate the change at Day 30. A positive number change from baseline indicates an increase in tears (improvement).