A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease

• ClinicalTrials.gov Identifier: NCT01664949
• Recruitment Status: Completed
• First Posted: August 14, 2012
• Results First Posted: June 8, 2015
• Last Update Posted: September 21, 2015
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief Summary:

This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops (OPTIVE™) in subjects with dry eye disease.

Condition or disease	Intervention/treatment	Phase
Dry Eye Disease	Drug: Carboxymethylcellulose Based Eye Drop Formulation A; Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 460 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: January 2013
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: May 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Carboxymethylcellulose Based Eye Drop Formulation A; Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.	Drug: Carboxymethylcellulose Based Eye Drop Formulation A; Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
Active Comparator: OPTIVE™; Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.	Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops; Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.; Other Names: REFRESH OPTIVE™; OPTAVA™

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90 [ Time Frame: Baseline, Day 90 ]
   The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). A negative number change from Baseline indicates improvement.

Secondary Outcome Measures :

1. Change From Baseline in Tear Break-up Time (TBUT) [ Time Frame: Baseline, Day 90 ]
   TBUT is the time in seconds for the tear film to visually break up after a complete blink. The average of 3 consecutive observations is reported for each participant. The longer it takes, the more stable the tear film. The eye with the shorter average TBUT at Baseline was used for analysis. A positive number change from Baseline indicates improvement.
2. Change From Baseline in Corneal Staining [ Time Frame: Baseline, Day 90 ]
   Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.
3. Change From Baseline in Conjunctival Staining [ Time Frame: Baseline, Day 90 ]
   Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). Conjunctival staining has 2 zones, nasal and temporal, which are added together to provide the total staining score. The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.
4. Change From Baseline in the Schirmer Test [ Time Frame: Baseline, Day 90 ]
   The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Have used artificial tears for dry eye

Exclusion Criteria:

• Start date of over the counter, herbal, prescription or nutritional supplements that may affect dry eye or vision within 3 months prior to study start or an anticipated change in dosage during the study
• History of eye surgery or trauma in the 6 months prior to study start
• Current use or use within 2 weeks of study start, of topical eye medications.

Contacts and Locations

Locations

Australia, New South Wales

Randwick, New South Wales, Australia

Belgium

Leuven, Belgium

France

Marseille, France

Tours Cedex, France

Germany

Freiburg, Germany

Italy

Padova, Italy

Parma, Italy

Russian Federation

Moscow, Russian Federation

Spain

Huelva, Spain

Valencia, Spain

United Kingdom

Southampton, Hampshire, United Kingdom

Great Yarmouth, Norfolk, United Kingdom

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Medical Director; Allergan

More Information

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01664949
• Other Study ID Numbers: 11002X-001; 2012-002238-35 ( EudraCT Number )
• First Posted: August 14, 2012
• Results First Posted: June 8, 2015
• Last Update Posted: September 21, 2015
• Last Verified: September 2015

Additional relevant MeSH terms:

Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Carboxymethylcellulose Sodium; Ophthalmic Solutions; Lubricant Eye Drops; Pharmaceutical Solutions; Laxatives; Gastrointestinal Agents