Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease
Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT01459588
Collaborator
(none)
315
1
4
4.5
70
Study Details
Study Description
Brief Summary
This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
315 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Actual Study Start Date
:
Oct 1, 2011
Actual Primary Completion Date
:
Feb 15, 2012
Actual Study Completion Date
:
Feb 15, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
Other Names:
|
| Experimental: 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. |
Drug: 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.
Other Names:
|
| Active Comparator: Carboxymethylcellulose 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. |
Drug: 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.
Other Names:
|
| Active Comparator: 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. |
Drug: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Ocular Surface Disease Index© Questionnaire Score [Baseline, Day 30]
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.
Secondary Outcome Measures
- Change From Baseline in Tear Break-up Time [Baseline, Day 30]
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.
- Change From Baseline in Corneal Staining [Baseline, Day 30]
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).
- Change From Baseline in Conjunctival Staining [Baseline, Day 30]
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).
- Change From Baseline in Schirmer Test Results [Baseline, Day 30]
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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Petaluma | California | United States |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Medical Director, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT01459588
Other Study ID Numbers:
- 10146X-001
First Posted:
Oct 25, 2011
Last Update Posted:
Apr 16, 2019
Last Verified:
Apr 1, 2019
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops |
|---|---|---|---|---|
| Arm/Group Description | 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 (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 (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 (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| Period Title: Overall Study | ||||
| STARTED | 105 | 51 | 103 | 56 |
| COMPLETED | 104 | 49 | 102 | 55 |
| NOT COMPLETED | 1 | 2 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 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 (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 (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 (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. | Total of all reporting groups |
| Overall Participants | 105 | 51 | 103 | 56 | 315 |
| Age, Customized (Number) [Number] | |||||
| <30 years |
9
8.6%
|
5
9.8%
|
6
5.8%
|
5
8.9%
|
25
7.9%
|
| 30 to 40 years |
10
9.5%
|
3
5.9%
|
12
11.7%
|
3
5.4%
|
28
8.9%
|
| >40 years |
86
81.9%
|
43
84.3%
|
85
82.5%
|
48
85.7%
|
262
83.2%
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
83
79%
|
44
86.3%
|
87
84.5%
|
41
73.2%
|
255
81%
|
| Male |
22
21%
|
7
13.7%
|
16
15.5%
|
15
26.8%
|
60
19%
|
Outcome Measures
| Title | Change From Baseline in Ocular Surface Disease Index© Questionnaire Score |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population included all randomized participants. |
| Arm/Group Title | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops |
|---|---|---|---|---|
| Arm/Group Description | 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 (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 (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 (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| Measure Participants | 105 | 51 | 103 | 56 |
| Baseline |
41.48
(14.797)
|
38.27
(12.825)
|
40.28
(13.509)
|
40.18
(13.443)
|
| Change from baseline at Day 30 |
-15.66
(14.717)
|
-9.78
(17.986)
|
-14.59
(15.090)
|
-13.77
(16.112)
|
| Title | Change From Baseline in Tear Break-up Time |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population included all randomized participants. |
| Arm/Group Title | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops |
|---|---|---|---|---|
| Arm/Group Description | 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 (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 (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 (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| Measure Participants | 105 | 51 | 103 | 56 |
| Baseline |
4.92
(1.790)
|
4.61
(1.739)
|
4.94
(1.808)
|
5.06
(1.699)
|
| Change from baseline at Day 30 |
1.36
(2.848)
|
1.21
(2.521)
|
1.33
(2.497)
|
1.06
(2.018)
|
| Title | Change From Baseline in Corneal Staining |
|---|---|
| Description | 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). |
| Time Frame | Baseline, Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population included all randomized participants. |
| Arm/Group Title | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops |
|---|---|---|---|---|
| Arm/Group Description | 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 (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 (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 (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| Measure Participants | 105 | 51 | 103 | 56 |
| Baseline |
4.9
(3.84)
|
5.0
(3.76)
|
5.0
(3.92)
|
4.7
(3.24)
|
| Change from baseline at Day 30 |
-0.7
(2.90)
|
0.1
(3.17)
|
-1.5
(2.37)
|
-1.4
(2.89)
|
| Title | Change From Baseline in Conjunctival Staining |
|---|---|
| Description | 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). |
| Time Frame | Baseline, Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population included all randomized participants. |
| Arm/Group Title | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops |
|---|---|---|---|---|
| Arm/Group Description | 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 (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 (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 (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| Measure Participants | 105 | 51 | 103 | 56 |
| Baseline |
6.7
(5.69)
|
6.3
(4.77)
|
6.1
(4.41)
|
6.7
(5.37)
|
| Change from baseline at Day 30 |
-0.6
(4.17)
|
0.5
(3.77)
|
-1.2
(3.70)
|
-0.8
(3.70)
|
| Title | Change From Baseline in Schirmer Test Results |
|---|---|
| Description | 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). |
| Time Frame | Baseline, Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population included all randomized participants. |
| Arm/Group Title | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops |
|---|---|---|---|---|
| Arm/Group Description | 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 (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 (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 (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| Measure Participants | 105 | 51 | 103 | 56 |
| Baseline |
10.3
(7.37)
|
8.4
(7.26)
|
10.4
(6.79)
|
10.1
(7.60)
|
| Change from baseline at Day 30 |
1.8
(6.97)
|
2.4
(6.30)
|
2.0
(6.27)
|
2.6
(6.59)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops | ||||
| Arm/Group Description | 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 (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 (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 (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. | ||||
All Cause Mortality |
||||||||
| Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/105 (1%) | 0/51 (0%) | 0/103 (0%) | 1/56 (1.8%) | ||||
| Hepatobiliary disorders | ||||||||
| Bile duct stone | 1/105 (1%) | 0/51 (0%) | 0/103 (0%) | 0/56 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Ankle fracture | 0/105 (0%) | 0/51 (0%) | 0/103 (0%) | 1/56 (1.8%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/105 (0%) | 0/51 (0%) | 0/103 (0%) | 0/56 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
| clinicaltrials@allergan.com |
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT01459588
Other Study ID Numbers:
- 10146X-001
First Posted:
Oct 25, 2011
Last Update Posted:
Apr 16, 2019
Last Verified:
Apr 1, 2019