Dry Eye Syndromes
Conditions
Brief summary
This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.
Interventions
DRUGCarboxymethylcellulose Based Eye Drop
Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
DRUGCarboxymethylcellulose Sodium 0.5%
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Sponsors
Allergan
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
No
Inclusion criteria
* Used artificial tears for dry eye * Visual acuity of at least 20/32 (while wearing glasses, if necessary).
Exclusion criteria
* Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study * Herpes keratitis in the last 6 months * Cataract surgery, laser-assisted in situ keratomileusis \[LASIK\], or photorefractive keratectomy, within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score | Baseline, Day 90 | The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Tear Break-up Time (TBUT) | Baseline, Day 90 | TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is used for the calculations and is defined as the eye with the shortest average TBUT at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening. |
| Change From Baseline in Corneal Staining Score | Baseline, Day 90 | Total corneal staining with fluorescein was measured in the worse eye using a 6-point scale where 0= none, no staining (best) to 5=severe staining (worst). The total score is calculated as the sum of 5 regions of the cornea, resulting in a possible minimum score of 0 and a maximum possible score of 25 (severe staining score of 5 in all 5 regions). The worse eye is defined as the eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement). |
| Change From Baseline in Conjunctival Staining Score | Baseline, Day 90 | Total conjunctival staining with lissamine green was measured in the worse eye using a 6-point scale where 0= none (best), no staining to 5=severe staining (worst). The total score is calculated as the sum of the 6 regions of the conjunctiva, resulting in a minimum possible score of 0 maximum possible score of 30 (severe staining score of 5 in 6 regions). The worse eye is defined as eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement). |
| Change From Baseline in the Schirmer Test | Baseline, Day 90 | The Schirmer Test measures tears produced by the eye over 5 minutes using a paper strip inserted into the eye. The results indicate the presence of dry eye (Normal = greater than 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 defined as the eye with the lowest score at baseline is used to calculate the change at Day 90. A positive number change from baseline indicates an increase in tears (improvement). |
Countries
Australia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OM3 Tear Carboxymethylcellulose based eye drop \[Omega-3 (OM3) Tear\] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. | 120 |
| REFRESH OPTIVE® ADVANCED Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. | 122 |
| Total | 242 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Other Miscellaneous Reasons | 0 | 1 |
| Overall Study | Withdrawal of Consent | 1 | 1 |
Baseline characteristics
| Characteristic | OM3 Tear | REFRESH OPTIVE® ADVANCED | Total |
|---|---|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 17.3 | 52.8 years STANDARD_DEVIATION 16.7 | 53.5 years STANDARD_DEVIATION 17 |
| Age, Customized 30 to 40 years | 11 participants | 18 participants | 29 participants |
| Age, Customized < 30 years | 16 participants | 14 participants | 30 participants |
| Age, Customized > 40 years | 93 participants | 90 participants | 183 participants |
| Sex: Female, Male Female | 84 Participants | 95 Participants | 179 Participants |
| Sex: Female, Male Male | 36 Participants | 27 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 120 | 0 / 122 |
| serious Total, serious adverse events | 1 / 120 | 1 / 122 |
Outcome results
Primary
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.
Time frame: Baseline, Day 90
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OM3 Tear | Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score | Baseline | 41.12 score on a scale | Standard Deviation 12.68 |
| OM3 Tear | Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score | Change at Day 90 | -15.61 score on a scale | Standard Deviation 16.52 |
| REFRESH OPTIVE® ADVANCED | Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score | Baseline | 39.63 score on a scale | Standard Deviation 11.33 |
| REFRESH OPTIVE® ADVANCED | Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score | Change at Day 90 | -13.16 score on a scale | Standard Deviation 17.71 |
Secondary
Change From Baseline in Conjunctival Staining Score
Total conjunctival staining with lissamine green was measured in the worse eye using a 6-point scale where 0= none (best), no staining to 5=severe staining (worst). The total score is calculated as the sum of the 6 regions of the conjunctiva, resulting in a minimum possible score of 0 maximum possible score of 30 (severe staining score of 5 in 6 regions). The worse eye is defined as eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Time frame: Baseline, Day 90
Population: ITT population included all randomized participants. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OM3 Tear | Change From Baseline in Conjunctival Staining Score | Baseline | 6.73 score on a scale | Standard Deviation 5.65 |
| OM3 Tear | Change From Baseline in Conjunctival Staining Score | Change at Day 90 | -1.76 score on a scale | Standard Deviation 4.42 |
| REFRESH OPTIVE® ADVANCED | Change From Baseline in Conjunctival Staining Score | Baseline | 5.87 score on a scale | Standard Deviation 4.46 |
| REFRESH OPTIVE® ADVANCED | Change From Baseline in Conjunctival Staining Score | Change at Day 90 | -1.18 score on a scale | Standard Deviation 4.03 |
Secondary
Change From Baseline in Corneal Staining Score
Total corneal staining with fluorescein was measured in the worse eye using a 6-point scale where 0= none, no staining (best) to 5=severe staining (worst). The total score is calculated as the sum of 5 regions of the cornea, resulting in a possible minimum score of 0 and a maximum possible score of 25 (severe staining score of 5 in all 5 regions). The worse eye is defined as the eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Time frame: Baseline, Day 90
Population: ITT population included all randomized participants. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OM3 Tear | Change From Baseline in Corneal Staining Score | Baseline | 4.49 score on a scale | Standard Deviation 3.39 |
| OM3 Tear | Change From Baseline in Corneal Staining Score | Change at Day 90 | -1.49 score on a scale | Standard Deviation 2.37 |
| REFRESH OPTIVE® ADVANCED | Change From Baseline in Corneal Staining Score | Baseline | 4.51 score on a scale | Standard Deviation 3.29 |
| REFRESH OPTIVE® ADVANCED | Change From Baseline in Corneal Staining Score | Change at Day 90 | -0.58 score on a scale | Standard Deviation 2.7 |
Secondary
Change From Baseline in Tear Break-up Time (TBUT)
TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is used for the calculations and is defined as the eye with the shortest average TBUT at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening.
Time frame: Baseline, Day 90
Population: ITT population included all randomized participants. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OM3 Tear | Change From Baseline in Tear Break-up Time (TBUT) | Baseline | 4.77 seconds | Standard Deviation 1.68 |
| OM3 Tear | Change From Baseline in Tear Break-up Time (TBUT) | Change at Day 90 | 1.12 seconds | Standard Deviation 1.93 |
| REFRESH OPTIVE® ADVANCED | Change From Baseline in Tear Break-up Time (TBUT) | Baseline | 4.93 seconds | Standard Deviation 1.74 |
| REFRESH OPTIVE® ADVANCED | Change From Baseline in Tear Break-up Time (TBUT) | Change at Day 90 | 1.34 seconds | Standard Deviation 2.62 |
Secondary
Change From Baseline in the Schirmer Test
The Schirmer Test measures tears produced by the eye over 5 minutes using a paper strip inserted into the eye. The results indicate the presence of dry eye (Normal = greater than 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 defined as the eye with the lowest score at baseline is used to calculate the change at Day 90. A positive number change from baseline indicates an increase in tears (improvement).
Time frame: Baseline, Day 90
Population: ITT population included all randomized participants. n is the number of participants in the category with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OM3 Tear | Change From Baseline in the Schirmer Test | Baseline | 9.91 mm | Standard Deviation 7.1 |
| OM3 Tear | Change From Baseline in the Schirmer Test | Change at Day 90 | 1.40 mm | Standard Deviation 7.13 |
| REFRESH OPTIVE® ADVANCED | Change From Baseline in the Schirmer Test | Baseline | 9.85 mm | Standard Deviation 6.82 |
| REFRESH OPTIVE® ADVANCED | Change From Baseline in the Schirmer Test | Change at Day 90 | 1.38 mm | Standard Deviation 7.21 |