Trial · NCT01664949

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

NCT01664949, Phase 3, Completed, Allergan; results first posted 2015-06-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease. Trials, record NCT01664949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01664949

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease
NCT number: NCT01664949
Status: Completed
Phases: Phase 3
Enrollment: 460 participants, actual
Lead sponsor: Allergan
Conditions: Dry Eye Disease
Interventions: Carboxymethylcellulose Based Eye Drop Formulation A, Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops
First posted: 2012-08-14
Last updated: 2015-09-21
Other registries' IDs: eudract:2012-002238-35
Results first posted: 2015-06-08

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90	Baseline, Day 90	Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.	score on a scale	MEAN
SECONDARY	Change From Baseline in Tear Break-up Time (TBUT)	Baseline, Day 90	Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.	seconds	MEAN
SECONDARY	Change From Baseline in Corneal Staining	Baseline, Day 90	Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.	score on a scale	MEAN
SECONDARY	Change From Baseline in Conjunctival Staining	Baseline, Day 90	Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.	score on a scale	MEAN
SECONDARY	Change From Baseline in the Schirmer Test	Baseline, Day 90	Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.	mm/5 minutes	MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90	Carboxymethylcellulose Based Eye Drop Formulation A	Baseline	41.77	Standard Deviation 14.018	score on a scale
Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90	OPTIVE™	Baseline	40.92	Standard Deviation 13.310	score on a scale
Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90	Carboxymethylcellulose Based Eye Drop Formulation A	Change from Baseline at Day 90 (n=181,185)	-16.88	Standard Deviation 17.496	score on a scale
Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90	OPTIVE™	Change from Baseline at Day 90 (n=181,185)	-15.97	Standard Deviation 16.146	score on a scale
Change From Baseline in Tear Break-up Time (TBUT)	Carboxymethylcellulose Based Eye Drop Formulation A	Baseline	4.50	Standard Deviation 1.868	seconds
Change From Baseline in Tear Break-up Time (TBUT)	OPTIVE™	Baseline	4.44	Standard Deviation 1.894	seconds
Change From Baseline in Tear Break-up Time (TBUT)	Carboxymethylcellulose Based Eye Drop Formulation A	Change from Baseline at Day 90 (n=181,185)	2.69	Standard Deviation 5.167	seconds
Change From Baseline in Tear Break-up Time (TBUT)	OPTIVE™	Change from Baseline at Day 90 (n=181,185)	2.24	Standard Deviation 3.262	seconds
Change From Baseline in Corneal Staining	Carboxymethylcellulose Based Eye Drop Formulation A	Baseline	1.5	Standard Deviation 0.99	score on a scale
Change From Baseline in Corneal Staining	OPTIVE™	Baseline	1.6	Standard Deviation 0.99	score on a scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Carboxymethylcellulose Based Eye Drop Formulation A	224
Overall Study	STARTED	OPTIVE™	236
Overall Study	COMPLETED	Carboxymethylcellulose Based Eye Drop Formulation A	200
Overall Study	COMPLETED	OPTIVE™	211
Overall Study	NOT COMPLETED	Carboxymethylcellulose Based Eye Drop Formulation A	24
Overall Study	NOT COMPLETED	OPTIVE™	25

Source ClinicalTrials.gov

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Eye irritation	Eye disorders	Carboxymethylcellulose Based Eye Drop Formulation A	15	224
other	Eye irritation	Eye disorders	OPTIVE™	6	236
serious	Atrial fibrillation	Cardiac disorders	Carboxymethylcellulose Based Eye Drop Formulation A	1	224
serious	Atrial fibrillation	Cardiac disorders	OPTIVE™	0	236
serious	Pyelonephritis acute	Infections and infestations	Carboxymethylcellulose Based Eye Drop Formulation A	1	224
serious	Pyelonephritis acute	Infections and infestations	OPTIVE™	0	236
serious	Cardiac failure	Cardiac disorders	Carboxymethylcellulose Based Eye Drop Formulation A	1	224
serious	Cardiac failure	Cardiac disorders	OPTIVE™	0	236
serious	Myocardial infarction	Cardiac disorders	Carboxymethylcellulose Based Eye Drop Formulation A	1	224
serious	Myocardial infarction	Cardiac disorders	OPTIVE™	0	236

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Carboxymethylcellulose Based Eye Drop Formulation A
Total, all-cause mortality	OPTIVE™
Total, other adverse events	Carboxymethylcellulose Based Eye Drop Formulation A	15	224
Total, other adverse events	OPTIVE™	6	236
Total, serious adverse events	Carboxymethylcellulose Based Eye Drop Formulation A	5	224
Total, serious adverse events	OPTIVE™	4	236

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Carboxymethylcellulose Based Eye Drop Formulation A vs OPTIVE™: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01664949

GET https://conductscience.org/api/trials/v1/NCT01664949/events?page=2

API reference For AI assistants