Dry Eye DiseasePhase 2NCT05238597
A Study to Evaluate the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease
A Phase 2 study testing A197 Ophthalmic Solution and Active Comparator in people with Dry Eye Disease, run by Aramis Biosciences, Inc. at 24 sites in United States.
Trial summary
The objectives of this trial are to assess the safety, tolerability and efficacy of A197 ophthalmic solution in comparison to a vehicle control in the treatment of subjects with Dry Eye Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- A197 Ophthalmic Solution and Active Comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 24 sitesUnited States
- Study dates
- 25 Jan 2022to 24 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained prior to any study-related assessments
- Have a history of Dry Eye Disease in both eyes for at least 12 months prior to Visit 1
- Willing and able to follow instructions and can be present for required study visits
Who cannot join
- Women who are pregnant or breastfeeding
- Use of topical ophthalmic medications, artificial tears, eye drops and gels in either eye
- Use of contact lenses within 90 days prior to Visit 1 and throughout the study
- Have had an ocular infection in either eye within 90 days prior to Visit 1
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Aramis Site 113
Birmingham, Alabama, 35233
Aramis Site 123
Cranberry Township, Pennsylvania, 16066
Aramis Site 101
Delray Beach, Florida, 33484
Aramis Site 118
Edgewood, Kentucky, 41017
Aramis Site 121
Garden Grove, California, 92843
Aramis Site 110
Garner, North Carolina, 27529
Aramis Site 120
Glendale, California, 95817
Aramis Site 115
Goodlettsville, Tennessee, 37072
Aramis Site 112
Jacksonville, Florida, 32204
Aramis Site 114
Kansas City, Missouri, 64111
Aramis Site 104
Lakeway, Texas, 78738
Aramis Site 117
Largo, Florida, 33773
Aramis Site 108
Las Vegas, Nevada, 89119
Aramis Site 106
Long Beach, California, 90805
Aramis Site 124
Los Angeles, California, 90013
Aramis Site 119
Mason, Ohio, 45040
Aramis Site 103
Memphis, Tennessee, 38119
Aramis Site 107
Murrieta, California, 92562
Aramis Site 102
Newport Beach, California, 92663
Aramis Site 116
Petaluma, California, 94954
Aramis Site 109
Rancho Cordova, California, 95670
Aramis Site 105
San Antonio, Texas, 78215
Aramis Site 122
Shelby, North Carolina, 28150
Aramis Site 111
St Louis, Missouri, 63128
About this study
Official title: A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease
The objectives of this trial are to assess the safety, tolerability and efficacy of A197 ophthalmic solution in comparison to a vehicle control in the treatment of subjects with Dry Eye Disease.
- Conditions
- Dry Eye Disease
- Being tested
- A197 Ophthalmic Solution, A197 Vehicle Control, Active Comparator
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A197 Ophthalmic SolutionDrug
A197 Ophthalmic Solution
A197 Vehicle ControlDrug
A197 Vehicle Control
Active ComparatorDrug
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| A197 Ophthalmic Solution, High Dose | Experimental | Not described Receives: Drug: A197 Ophthalmic Solution |
| A197 Ophthalmic Solution, Low Dose | Experimental | Not described Receives: Drug: A197 Ophthalmic Solution |
| A197 Vehicle Control | Placebo comparator | Not described Receives: Drug: A197 Vehicle Control |
| Active Comparator | Active comparator | Not described Receives: Drug: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total corneal fluorescein staining (CFS)
Corneal Fluorescein Staining (tCFS) is graded based on a modified National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 regions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-4 using 0.5 unit increments; 0 corresponds to no staining, 4 corresponds to maximum staining. The total score is the sum of the 5 regions ranging from 0-20.
Measured: 12 Weeks
Secondary outcomes (3)
Change from baseline in eye dryness via the Visual Analogue Scale (VAS)
Eye dryness is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no symptoms and 100 to severe symptoms.
Measured: 12 Weeks
Change from baseline in lissamine green conjunctival staining (LGCS)
Lissamine green conjunctival staining (LGCS) is graded based on the NEI Scale. The NEI scale divides the conjunctiva in 6 regions with the score for each region ranging from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 6 regions ranging from 0-18.
Measured: 12 Weeks
Change from baseline in bulbar conjunctival hyperemia (CCLRU)
Bulbar conjunctival hyperemia is graded based on the Cornea and Contact Lens Research Unit (CCLRU) grading scale where 0 corresponds to none, 4 corresponds to severe.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start25 Jan 2022
- Primary completion24 Jan 2023
- Study completion24 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aramis Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David S Tierney, MD, Study director, Aramis Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238597
- Sponsor's protocol ID
- A197-CS-201
- Status last verified
- May 2023
- First submitted
- 3 Feb 2022
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
PubMed 36729473
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT05238597
- Acronym / sponsor ID
- A197-CS-201
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Aramis Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this trial are to assess the safety, tolerability and efficacy of A197 ophthalmic solution in comparison to a vehicle control in the treatment of subjects with Dry Eye Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A197 Ophthalmic Solution, High Dose | Experimental | Drug: A197 Ophthalmic Solution |
| A197 Ophthalmic Solution, Low Dose | Experimental | Drug: A197 Ophthalmic Solution |
| A197 Vehicle Control | Placebo comparator | Drug: A197 Vehicle Control |
| Active Comparator | Active comparator | Drug: Active Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent must be obtained prior to any study-related assessments
- Have a history of Dry Eye Disease in both eyes for at least 12 months prior to Visit 1
- Willing and able to follow instructions and can be present for required study visits
Key exclusion criteria (4 listed)
- Women who are pregnant or breastfeeding
- Use of topical ophthalmic medications, artificial tears, eye drops and gels in either eye
- Use of contact lenses within 90 days prior to Visit 1 and throughout the study
- Have had an ocular infection in either eye within 90 days prior to Visit 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A197 Ophthalmic SolutionA197 Ophthalmic Solution | Drug | A197 Ophthalmic Solution, High Dose, A197 Ophthalmic Solution, Low Dose |
| A197 Vehicle ControlA197 Vehicle Control | Drug | A197 Vehicle Control |
| Active ComparatorActive Comparator | Drug | Active Comparator |
Primary outcome
Change from baseline in total corneal fluorescein staining (CFS)
Time frame: 12 Weeks
Corneal Fluorescein Staining (tCFS) is graded based on a modified National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 regions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-4 using 0.5 unit increments; 0 corresponds to no staining, 4 corresponds to maximum staining. The total score is the sum of the 5 regions ranging from 0-20.
3 secondary outcomes
Change from baseline in eye dryness via the Visual Analogue Scale (VAS)
Time frame: 12 Weeks
Change from baseline in lissamine green conjunctival staining (LGCS)
Time frame: 12 Weeks
Change from baseline in bulbar conjunctival hyperemia (CCLRU)
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 36729473Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Tierney, MD study director
Aramis Biosciences
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A197 Ophthalmic Solution and Active Comparator in people with Dry Eye Disease, run by Aramis Biosciences, Inc. at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in total corneal fluorescein staining (CFS) (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05238597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.