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Safety and Tolerability of Artificial Tears in Dry Eye Subjects

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ClinicalTrials.gov Identifier: NCT00932477
Recruitment Status : Completed
First Posted : July 3, 2009
Results First Posted : December 13, 2011
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator)
Condition Dry Eye Syndrome
Interventions Drug: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Drug: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Drug: Glycerin and Polysorbate 80 based artificial tear
Enrollment 47
Recruitment Details  
Pre-assignment Details This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 products in a randomly assigned order. The subject used 1 product at a time for a duration of 1 week before switching to the next assigned product (e.g., with treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA).
Arm/Group Title Sequence ABC Sequence ACB Sequence BAC Sequence BCA Sequence CAB Sequence CBA
Hide Arm/Group Description Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2 Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1 Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2 Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1
Period Title: Treatment 1
Started 7 8 9 7 8 8
Completed 7 8 9 7 8 8
Not Completed 0 0 0 0 0 0
Period Title: Treatment 2
Started 7 8 9 7 8 8
Completed 7 8 9 7 8 8
Not Completed 0 0 0 0 0 0
Period Title: Treatment 3
Started 7 8 9 7 8 8
Completed 7 8 9 7 8 8
Not Completed 0 0 0 0 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description All Study Participants
Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
<40 years 7
>=40 years 40
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
42
  89.4%
Male
5
  10.6%
1.Primary Outcome
Title Tolerability Questionnaire Mean Scores at 1 Week
Hide Description Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst.
Time Frame 1 Week
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, which consisted of all patients who started the study (randomized) and received treatment.
Arm/Group Title Artificial Tear Formulation 1 Artificial Tear Formulation 2 Glycerin and Polysorbate 80 Based Artificial Tear
Hide Arm/Group Description:
Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Glycerin and Polysorbate 80 based artificial tear
Overall Number of Participants Analyzed 47 47 47
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
How comfortable is drop in the eye? 70.1  (30.01) 70.7  (26.63) 57.3  (31.40)
How soothing is drop in the eye? 65.1  (31.67) 65.9  (27.68) 53.4  (32.63)
How moistening/lubricating is drop in the eye? 68.0  (27.79) 65.9  (28.41) 57.4  (31.51)
How clear is vision with drop in the eye? 66.0  (30.91) 61.1  (30.78) 53.0  (30.87)
How much stickiness with drop in the eye? 24.6  (29.44) 19.5  (23.82) 31.4  (29.03)
How much blur with drop in the eye? 33.2  (29.88) 32.4  (30.52) 48.9  (30.83)
How much burning/stinging with drop in the eye? 14.8  (22.48) 14.3  (22.40) 27.9  (30.62)
How much discomfort with drop in the eye? 19.3  (24.84) 18.9  (26.27) 27.1  (28.57)
2.Secondary Outcome
Title Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week
Hide Description Number of patients with at least one severity grade increase in biomicroscopy findings at 1 week. Eyes are examined with a special microscope (biomicroscopy), and findings scored using a 5-point scale (0=none, +0.5=trace, +1=mild, +2=moderate, +3=severe). An increase in severity grade indicates worsening.
Time Frame 1 Week
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, which consisted of all patients who started the study (randomized) and received treatment.
Arm/Group Title Artificial Tear Formulation 1 Artificial Tear Formulation 2 Glycerin and Polysorbate 80 Based Artificial Tear
Hide Arm/Group Description:
Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Glycerin and Polysorbate 80 based artificial tear
Overall Number of Participants Analyzed 47 47 47
Measure Type: Number
Unit of Measure: Number of Patients
Pterygium (cornea) 1 0 0
Punctate keratitis (cornea) 0 1 2
Vital dye staining of cornea present 0 1 0
3.Secondary Outcome
Title Best-Corrected Visual Acuity (BCVA) Status at 1 Week
Hide Description BCVA status at 1 week reported as the number of patients whose scores were either "Better", "No Change", or "Worse" than their scores at baseline. The status was tabulated as number of lines read correctly at 1 week minus the number of lines read correctly at baseline. "Better" equals increase of 2 lines or more in at least 1 eye; "No Change" equals change between -2 to +2 lines in either eye; "Worse" equals decrease of 2 lines or more in at least 1 eye. BCVA is measured using a special eye chart and is reported as the number of lines (5 letters per line) read correctly.
Time Frame 1 Week
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, which consisted of all patients who started the study (randomized) and received treatment.
Arm/Group Title Artificial Tear Formulation 1 Artificial Tear Formulation 2 Glycerin and Polysorbate 80 Based Artificial Tear
Hide Arm/Group Description:
Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Glycerin and Polysorbate 80 based artificial tear
Overall Number of Participants Analyzed 47 47 47
Measure Type: Number
Unit of Measure: Number of Patients
Better 0 0 0
No Change 46 45 46
Worse 1 2 1
4.Secondary Outcome
Title The Number of Ophthalmic Adverse Events at 1 Week
Hide Description The number of ophthalmic adverse events (AE) at 1 week. An ophthalmic AE is any unfavorable and unintended sign, symptom, or disease related to the eye which occurs during the use of the study investigational product
Time Frame 1 Week
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, which consisted of all patients who started the study (randomized) and received treatment.
Arm/Group Title Artificial Tear Formulation 1 Artificial Tear Formulation 2 Glycerin and Polysorbate 80 Based Artificial Tear
Hide Arm/Group Description:
Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Glycerin and Polysorbate 80 based artificial tear
Overall Number of Participants Analyzed 47 47 47
Measure Type: Number
Unit of Measure: Number of adverse events
Eye pruritis (itching) 0 0 2
Abnormal sensation in eye 0 0 1
Erythema (redness) of eyelid 0 0 1
Eyelid irritation 0 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Artificial Tear Formulation 1 Artificial Tear Formulation 2 Glycerin and Polysorbate 80 Based Artificial Tear
Hide Arm/Group Description Formulation 1 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear Formulation 2 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear Glycerin and Polysorbate 80 based artificial tear
All-Cause Mortality
Artificial Tear Formulation 1 Artificial Tear Formulation 2 Glycerin and Polysorbate 80 Based Artificial Tear
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Artificial Tear Formulation 1 Artificial Tear Formulation 2 Glycerin and Polysorbate 80 Based Artificial Tear
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/47 (0.00%)   0/47 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Artificial Tear Formulation 1 Artificial Tear Formulation 2 Glycerin and Polysorbate 80 Based Artificial Tear
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/47 (0.00%)   0/47 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00932477     History of Changes
Other Study ID Numbers: AG9965-001
First Submitted: July 1, 2009
First Posted: July 3, 2009
Results First Submitted: November 9, 2011
Results First Posted: December 13, 2011
Last Update Posted: August 26, 2015