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

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459588
• Other study ID #: 10146X-001
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2011
• Est. completion date: February 15, 2012

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: February 15, 2012
• Est. primary completion date: February 15, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 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 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.
• 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 (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

References & Publications (1)

Simmons PA, Carlisle-Wilcox C, Vehige JG. Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial. Clin Ophthalmol. 2015 Apr 15;9:657-64. doi: 10.2147/OPTH.S74849. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Ocular Surface Disease Index© Questionnaire Score	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.	Baseline, Day 30
Secondary	Change From Baseline in Tear Break-up Time	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.	Baseline, Day 30
Secondary	Change From Baseline in Corneal Staining	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).	Baseline, Day 30
Secondary	Change From Baseline in Conjunctival Staining	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).	Baseline, Day 30
Secondary	Change From Baseline in Schirmer Test Results	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).	Baseline, Day 30