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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01664949

Enrollment

460

Registered

2012-08-14

Start date

2013-01-31

Completion date

2014-05-31

Last updated

2015-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

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.

Interventions

DRUGCarboxymethylcellulose 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.

DRUGCarboxymethylcellulose 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90	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

Measure	Time frame	Description
Change From Baseline in Tear Break-up Time (TBUT)	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.
Change From Baseline in Corneal Staining	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.
Change From Baseline in Conjunctival Staining	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.
Change From Baseline in the Schirmer Test	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.

Countries

Australia, Belgium, France, Germany, Italy, Russia, Spain, United Kingdom

Participant flow

Participants by arm

Arm	Count
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.	224
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.	236
Total	460

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	11	12
Overall Study	Lack of Efficacy	1	1
Overall Study	Lost to Follow-up	1	2
Overall Study	Other Miscellaneous Reasons	3	1
Overall Study	Personal Reasons	3	4
Overall Study	Protocol Violation	5	5

Baseline characteristics

Characteristic	Carboxymethylcellulose Based Eye Drop Formulation A	OPTIVE™	Total
Age, Customized 30 to 40 years	15 participants	15 participants	30 participants
Age, Customized < 30 years	9 participants 13.77	10 participants 13.65	19 participants
Age, Customized > 40 years	200 participants	211 participants	411 participants
Sex: Female, Male Female	182 Participants	189 Participants	371 Participants
Sex: Female, Male Male	42 Participants	47 Participants	89 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	15 / 224	6 / 236
serious Total, serious adverse events	5 / 224	4 / 236

Outcome results

Primary

Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 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.

Time frame: Baseline, Day 90