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This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of Dry Eye Disease (DED). Half of participants will receive Brimonidine and half will receive ophthalmic buffered saline (placebo).
Dry eye disease (DED) is a common ocular disorder involving the aberrant production and instability of tear film, which results in damage to the ocular surface and is correlated with symptoms of ocular discomfort.
This study will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study in the United States conducted at approximately 25 centers. Upon meeting the eligibility criteria, enrolled subjects will be randomly assigned in a 1:1 (test:control) fashion to receive either Brimonidine Nanoemulsion Eye Drops 0.20% investigational product (test) or ophthalmic buffered saline (placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCU-310 | Experimental | Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks |
|
| Placebos | Placebo Comparator | Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine Tartrate | Drug | Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score | The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. | Baseline, 4 weeks (Day 28) |
| Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores | Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome. | Baseline, 4 Weeks (Day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 2 Weeks (Day 14) in SANDE Score | The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. |
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Inclusion Criteria:
Aged 18 years or older.
Sign and date informed consent form approved by the IRB
History of Dry Eye Disease for ≥6 months
Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline (Day 1):
Symptomatic evidence of DED by having a global symptom score (Overall SANDE) ≥40 mm at Screening and Baseline (Day 1) visit
Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye
Women who satisfy one of the following:
8a. Are of child-bearing potential (WOCP) who are not pregnant or lactating and who are either abstinent or sexually active on an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study (i.e., until Day 28), OR 8b. Are post-menopausal or have undergone a sterilization procedure
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aesthetic Eye Care Institute/David Wirta, MD and Associates | Newport Beach | California | 92663 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | OCU-310 | Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks |
| FG001 | Placebo | Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 12, 2018 |
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| Placebos | Drug | Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks. |
|
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| Baseline, 2 weeks (Day 14) |
| Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores | Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome. | Baseline, 2 Weeks (Day 14) |
| Martel Medical Eye Group |
| Rancho Cordova |
| California |
| 95670 |
| United States |
| Rand Eye Institute | Pompano Beach | Florida | 33064 | United States |
| Chicago Cornea Consultants | Hoffman Estates | Illinois | 60169 | United States |
| Heart of America Eye Care, P. A. | Mission | Kansas | 66204 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Apex Eye- Kenwood | Cincinnati | Ohio | 45236 | United States |
| Apex Eye-Montgomery | Cincinnati | Ohio | 45242 | United States |
| Abrams Eye Center | Cleveland | Ohio | 44115 | United States |
| Scott and Christie Eyecare Associates | Cranberry Township | Pennsylvania | 16066 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
| Toyos Clinic | Nashville | Tennessee | 37215 | United States |
| Midtown Eye Physicans & Associates | Houston | Texas | 77004 | United States |
| Advanced Laser Vision & Surgical Institute | Houston | Texas | 77034 | United States |
| Revolution Research, Inc; Lake Travis Eye and Laser Center | Lakeway | Texas | 78734 | United States |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |
| Received at Least 1 Study Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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Randomized set: All randomized participants who previously signed the informed consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | OCU-310 | Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks |
| BG001 | Placebo | Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score | The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. | The Intention-to-treat (ITT) set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed is the number of participants with evaluable data at each time point. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 4 weeks (Day 28) |
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| Primary | Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores | Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome. | The ITT set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed is the number of participants with evaluable data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 Weeks (Day 28) |
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| Secondary | Change From Baseline to 2 Weeks (Day 14) in SANDE Score | The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. | The ITT set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed are those evaluable for this Outcome Measure and the Number Analyzed per Row is the number of participants with evaluable data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks (Day 14) |
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| Secondary | Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores | Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome. | The ITT set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed are those evaluable for this Outcome Measure and the Number Analyzed per Row is the number of participants with evaluable data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 Weeks (Day 14) |
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Adverse events were collected from the time of informed consent completion, throughout the study, and at early termination (Up to 28 Days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OCU-310 | Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks | 0 | 126 | 0 | 126 | 0 | 126 |
| EG001 | Placebo | Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks | 0 | 126 | 0 | 126 | 0 | 126 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vijay Tammara, VP, Strategic regulatory Operations | Ocugen | 484-328-4751 | Vijay.tammara@ocugen.com |
| Type | Description | Creation Date | Issued Date | Release Date | Posted Date |
|---|---|---|---|---|---|
| Correction Confirmed by FDA | The responsible party has corrected the violation. | Aug 3, 2022 | Aug 1, 2022 | Jun 29, 2022 | Aug 4, 2022 |
| Violation Identified by FDA | Failure to Submit. The entry for this clinical trial was not complete at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry. | Apr 19, 2022 | Apr 15, 2022 | Jul 15, 2020 | Apr 20, 2022 |
| Apr 25, 2022 |
| Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Change from Baseline at 4 weeks (Day 28) |
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| Superiority |
The endpoints were tested in a fixed sequence, proceeding to the next endpoint until a p-value >0.05 was found:
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