A Phase 3 interventional study of Carboxymethylcellulose Based Eye Drop Formulation A and Carboxymethylcellulose Based Eye Drop Formulation B in Dry Eye Syndromes, sponsored by Allergan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Allergan · Phase 3, Interventional, and Treatment
This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 315 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
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Exclusion Criteria:
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 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 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 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 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.
Also known as: Refresh Optive® Advanced Sensitive Eye Drops
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.
Also known as: Refresh Optive® Advanced 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.
Also known as: Optive® Sensitive Preservative-Free 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.
Also known as: Optive® Lubricant Eye Drops
Change From Baseline in Ocular Surface Disease Index© Questionnaire Score
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
Change From Baseline in Tear Break-up Time
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
Change From Baseline in Corneal Staining
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
Change From Baseline in Conjunctival Staining
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
Change From Baseline in Schirmer Test Results
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
| Milestone | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops |
|---|---|---|---|---|
| Started | 105 | 51 | 103 | 56 |
| Completed | 104 | 49 | 102 | 55 |
| Not completed | 1 | 2 | 1 | 1 |
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.
| Score on a scale | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops |
|---|---|---|---|---|
| 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 |
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.
| Seconds | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops |
|---|---|---|---|---|
| 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 |
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).
| Score on a scale | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops |
|---|---|---|---|---|
| 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 |
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).
| Score on as scale | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops |
|---|---|---|---|---|
| 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 |
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).
| millimeters | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops |
|---|---|---|---|---|
| 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 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formulation A | — | 1/105 (1%) | 0/105 (0%) |
| Carboxymethylcellulose Based Eye Drop Formulation B | — | 0/51 (0%) | 0/51 (0%) |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | — | 0/103 (0%) | 0/103 (0%) |
| Carboxymethylcellulose Based Lubricant Eye Drops | — | 1/56 (1.8%) | 0/56 (0%) |
| Event | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops |
|---|---|---|---|---|
| Ankle fractureInjury, poisoning and procedural complications | 0/105 | 0/51 | 0/103 | 1/56 |
| Bile duct stoneHepatobiliary disorders | 1/105 | 0/51 | 0/103 | 0/56 |
| Age, Customized(Participants) | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops | Total |
|---|---|---|---|---|---|
| <30 years | 9 | 5 | 6 | 5 | 25 |
| 30 to 40 years | 10 | 3 | 12 | 3 | 28 |
| >40 years | 86 | 43 | 85 | 48 | 262 |
| Sex: Female, Male(Participants) | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops | Total |
|---|---|---|---|---|---|
| Female | 83 | 44 | 87 | 41 | 255 |
| Male | 22 | 7 | 16 | 15 | 60 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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