Dry Eye SyndromePhase 2/3THEIA-1NCT03833388
Study of TOP1630 for Dry Eye Syndrome
A Phase 2/3 study testing TOP1630 0.1% Ophthalmic Solution TID OU in people with Dry Eye Syndrome, run by Topivert Pharma Ltd at 4 sites in United States.
Trial summary
In subjects with Dry Eye Syndrome (DES): The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- TOP1630 0.1% Ophthalmic Solution TID OU
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Feb 2019to 14 May 2019
- Phase
- Phase 2/3
- 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
- Be at least 18 years of age;
- Provide written informed consent;
- Have a reported history of dry eye;
- Have a history of use of eye drops for dry eye symptoms;
- Symptoms of dry eye syndrome including:
- Ocular discomfort
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- Conjunctival redness
- Tear film break up time
- Schirmer test score
- Signs of dry eye syndrome including:
- Conjunctival staining score
Who cannot join
- Have any clinically significant slit lamp findings at entry visit ;
- Be diagnosed with an ongoing ocular infection;
- Have any significant ocular lesion that could interfere with assessment of safety or efficacy or prevent study conduct in the opinion of the PI;
- Have any planned ocular and/or lid surgeries over the study period;
- Have an uncontrolled systemic disease;
- Be a woman who is pregnant, nursing or planning a pregnancy;
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- Be a woman of childbearing potential who is not using an acceptable means of birth control;
- Have a known allergy and/or sensitivity to the test article or its components;
- Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Central Maine Eye Care
Lewiston, Maine, 04240
Total Eye Care
Memphis, Tennessee, 38119
Suite 305, 775 Paramount Drive
Raynham, Massachusetts, 02767
About this study
Official title: A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of TOP1630 0.1% Ophthalmic Solution Compared to Placebo in Subjects With Moderate to Severe Dry Eye Syndrome
In subjects with Dry Eye Syndrome (DES):
The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.
Read the detailed description
This study is designed to assess the efficacy and safety of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome (DES).
Eligible subjects will be randomized double masked to either TOP1630 or placebo for a duration of 28 days' treatment.
- Conditions
- Dry Eye Syndrome
- Being tested
- TOP1630 0.1% Ophthalmic Solution TID OU, Placebo to TOP1630 0.1% Ophthalmic Solution TID OU
- 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.
TOP1630 0.1% Ophthalmic Solution TID OUDrug
Bilateral ocular drug administration
Placebo to TOP1630 0.1% Ophthalmic Solution TID OUDrug
Bilateral ocular drug administration
| Study group | Role | What they receive |
|---|---|---|
| TOP1630 Ophthalmic Solution | Experimental | Not described Receives: Drug: TOP1630 0.1% Ophthalmic Solution TID OU |
| Placebo to TOP1630 Ophthalmic Solution | Placebo comparator | Not described Receives: Drug: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular grittiness 6-point (0-5) scale
Ocular grittiness severity assessment
Measured: Day 29
Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region
Dry Eye Syndrome ocular staining assessment. Total region score: inferior, superior, central, temporal, and nasal.
Measured: Day 29
Secondary outcomes (5)
Ocular discomfort 5-point (0-4) scale
Ocular discomfort severity assessment
Measured: Day 29
Ocular dryness 6-point (0-5) scale
Ocular dryness severity assessment
Measured: Day 29
Conjunctival lissamine green staining score 5-point (0-4) scale each region
Dry Eye Syndrome ocular staining assessment. Conjunctival sum score: temporal and nasal.
Measured: Day 29
Corneal lissamine green staining score 5-point (0-4) scale each region
Dry Eye Syndrome ocular staining assessment. Corneal sum score: inferior, superior and central.
Measured: Day 29
Worst ocular symptom 6-point (0-5) scale
Most severe baseline symptom from reported daily symptoms
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start13 Feb 2019
- Primary completion14 May 2019
- Study completion14 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topivert Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833388
- Sponsor's protocol ID
- TOP1630-TV-05
- Acronym
- THEIA-1
- Status last verified
- Aug 2019
- First submitted
- 5 Feb 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of TOP1630 0.1% Ophthalmic Solution Compared to Placebo in Subjects With Moderate to Severe Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT03833388
- Acronym / sponsor ID
- THEIA-1 / TOP1630-TV-05
- Conditions
- Dry Eye Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Topivert Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 7 Feb 2019 (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.
In subjects with Dry Eye Syndrome (DES):
The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.
Detailed description
This study is designed to assess the efficacy and safety of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome (DES).
Eligible subjects will be randomized double masked to either TOP1630 or placebo for a duration of 28 days' treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOP1630 Ophthalmic Solution | Experimental | Drug: TOP1630 0.1% Ophthalmic Solution TID OU |
| Placebo to TOP1630 Ophthalmic Solution | Placebo comparator | Drug: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be at least 18 years of age;
- Provide written informed consent;
- Have a reported history of dry eye;
- Have a history of use of eye drops for dry eye symptoms;
- Ocular discomfort
Key exclusion criteria (9 listed)
- Have any clinically significant slit lamp findings at entry visit ;
- Be diagnosed with an ongoing ocular infection;
- Have any significant ocular lesion that could interfere with assessment of safety or efficacy or prevent study conduct in the opinion of the PI;
- Have any planned ocular and/or lid surgeries over the study period;
- Have an uncontrolled systemic disease;
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 |
|---|---|---|
| TOP1630 0.1% Ophthalmic Solution TID OUBilateral ocular drug administration | Drug | TOP1630 Ophthalmic Solution |
| Placebo to TOP1630 0.1% Ophthalmic Solution TID OUBilateral ocular drug administration | Drug | Placebo to TOP1630 Ophthalmic Solution |
Primary outcome
Ocular grittiness 6-point (0-5) scale
Time frame: Day 29
Ocular grittiness severity assessment
Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region
Time frame: Day 29
Dry Eye Syndrome ocular staining assessment. Total region score: inferior, superior, central, temporal, and nasal.
5 secondary outcomes
Ocular discomfort 5-point (0-4) scale
Time frame: Day 29
Ocular dryness 6-point (0-5) scale
Time frame: Day 29
Conjunctival lissamine green staining score 5-point (0-4) scale each region
Time frame: Day 29
Corneal lissamine green staining score 5-point (0-4) scale each region
Time frame: Day 29
Worst ocular symptom 6-point (0-5) scale
Time frame: Day 29
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 7 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TOP1630 0.1% Ophthalmic Solution TID OU in people with Dry Eye Syndrome, run by Topivert Pharma Ltd at 4 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 11 inclusion and 9 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Ocular grittiness 6-point (0-5) scale (time frame: Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2019.