Dry Eye SyndromePhase 2NCT03088605

Safety and Efficacy of TOP1630 for Dry Eye Syndrome

A Phase 2 study testing TOP1630 Ophthalmic Solution in people with Dry Eye Syndrome, run by ORA, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In subjects with Dry Eye Syndrome: The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo. The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome. 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 Ophthalmic Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 69 participants
Where: 1 siteUnited States
Study dates: 20 Feb 2017to 15 Jun 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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;
Additionally for Part 2
Symptoms of dry eye syndrome including:

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Ocular discomfort
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;

Show all 9Show fewer

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

1 site in 1 country.

United States1 site

Andover Eye Associates
Andover, Massachusetts, 01810

Other trials in United States

About this study

Official title: A Single-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of TOP1630 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Syndrome

In subjects with Dry Eye Syndrome:

The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo.

The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.

Read the detailed description

This study is designed to assess the safety, tolerability and efficacy of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome.

Eligible subjects will be randomized double masked to either TOP1630 or placebo.

Part 1 (time frame 12 days) comprises assessment of safety, tolerability and ocular comfort.

Part 2 (time frame 35 days) comprises assessment of safety, tolerability and efficacy

Conditions: Dry Eye Syndrome
Being tested: TOP1630 Ophthalmic Solution, Placebo to TOP1630 Ophthalmic Solution
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 Ophthalmic SolutionDrug
Bilateral ocular drug administration
Placebo to TOP1630 Ophthalmic SolutionDrug
Bilateral ocular drug administration

Study groups in NCT03088605
Study group	Role	What they receive
Active	Experimental	TOP1630 Ophthalmic Solution Receives: Drug: TOP1630 Ophthalmic Solution
Placebo	Placebo comparator	Placebo (Vehicle) Ophthalmic Solution Receives: Drug: Placebo to TOP1630 Ophthalmic Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Acuity
Visual Acuity will be measured using the EDTRS chart to assess changes from baseline
Measured: Part 1: 12 days time frame; Part 2: 35 days time frame
Slit-lamp Biomicroscopy
Slit lamp biomicroscopy exams will be performed to assess any changes from baseline; outcome measure is number of patients with no abnormalities
Measured: Part 1: 12 days time frame; Part 2: 35 days time frame
Drop Comfort Assessment
The comfort of the eye drop will be performed to assess changes from baseline. Drop Comfort Assessment Scale; 0-10; 0 being very comfortable and 10 being very uncomfortable
Measured: Part 1: 12 days time frame
Intraocular Pressure
a non-contact tonometer will be used to perform IOP to assess changes from baseline.
Measured: Part 1: 12 days time frame; Part 2: 35 days time frame
Corneal Sensitivity
The aesthesiometer will be used to perform corneal sensitivity to assess changes from baseline. Corneal Sensitivity Scale. Scale of 0-6
Measured: Part 1: 12 days time frame; Part 2: 35 days time frame
Undilated Fundoscopy
Non-Contact undilated fundoscopy exam will be performed to assess changes from baseline; outcome measure is number of patients with no abnormalities
Measured: Part 2: 35 days time frame
Vital Signs - Pulse
Changes in vital signs is performed to assess changes from baseline
Measured: Part 1: 12 days time frame; Part 2: 35 days time frame
Vital Signs - O2 Saturation
Changes in vital signs is performed to assess changes from baseline
Measured: Part 1: 12 days time frame; Part 2: 35 days time frame
Vital Signs - Systolic Blood Pressure
Changes in vital signs is performed to assess changes from baseline
Measured: Part 1: 12 days time frame; Part 2: 35 days time frame
Vital Signs - Diastolic Blood Pressure
Changes in vital signs is performed to assess changes from baseline
Measured: Part 1: 12 days time frame; Part 2: 35 days time frame

Secondary outcomes (6)

Ocular Discomfort
Ocular discomfort Scale severity assessment (0-4 scale where 0 = none and 4 = constant)
Measured: Part 2: 35 days time frame
Dry Eye Symptoms
Dry eye syndrome symptom assessment Scale (grittiness) (0-5 scale where 0 = none and 5 = worst)
Measured: Part 2: 35 days time frame
Dry Eye Signs
Dry eye syndrome staining Score assessments (total lissamine green staining score, 0-20 where 0 = no staining)
Measured: Part 2: 35 days time frame
Tear Film Break up Time
Tear film break up time measured (in seconds) after instillation of sodium fluorescein solution
Measured: Part 2: 35 days time frame
Schirmer's Test
Measurement of Schirmer test strips (mm length of moistened area after 5 minutes)
Measured: Part 2: 35 days time frame
Daily Symptom Assessment
Daily symptom assessment using diary cards - outcome for worst symptom, ie symptom with highest severity score at baseline for each patient; calculated using the daily average between visit 3b to visit 4b Ora Calibra Ocular Discomfort \& 4-Symptom Questionnaire (0-5 scale where 0 = none and 5 = worst)
Measured: Assessed daily between visit 3b (day 27) to visit 4b (day 35)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 201715 Jun 2017

First posted23 Mar 2017
Study start20 Feb 2017
Primary completion15 Jun 2017
Study completion15 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03088605
Sponsor's protocol ID: TOP1630-TV-04
Status last verified: Jan 2024
First submitted: 10 Mar 2017
Last updated: 14 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Dry Eye Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of TOP1630 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Syndrome
ClinicalTrials.gov ID: NCT03088605
Acronym / sponsor ID: TOP1630-TV-04
Conditions: Dry Eye Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: ORA, Inc.Industry (pharma, biotech, devices)
Collaborators: Topivert Pharma Ltd
Study start: 20 Feb 2017 (actual)
Primary completion: 15 Jun 2017 (actual)
Study completion: 15 Jun 2017 (actual)
First posted: 23 Mar 2017 (actual)
Results: Posted 14 Feb 2024

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:

The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo.

The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.

Detailed description

This study is designed to assess the safety, tolerability and efficacy of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome.

Eligible subjects will be randomized double masked to either TOP1630 or placebo.

Part 1 (time frame 12 days) comprises assessment of safety, tolerability and ocular comfort.

Part 2 (time frame 35 days) comprises assessment of safety, tolerability and efficacy

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
Active	Experimental	Drug: TOP1630 Ophthalmic SolutionTOP1630 Ophthalmic Solution
Placebo	Placebo comparator	Drug: Placebo to TOP1630 Ophthalmic SolutionPlacebo (Vehicle) Ophthalmic Solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 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;
Additionally for Part 2

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 Ophthalmic SolutionBilateral ocular drug administration	Drug	Active
Placebo to TOP1630 Ophthalmic SolutionBilateral ocular drug administration	Drug	Placebo

Primary outcome

Visual Acuity
Time frame: Part 1: 12 days time frame; Part 2: 35 days time frame
Visual Acuity will be measured using the EDTRS chart to assess changes from baseline
Slit-lamp Biomicroscopy
Time frame: Part 1: 12 days time frame; Part 2: 35 days time frame
Slit lamp biomicroscopy exams will be performed to assess any changes from baseline; outcome measure is number of patients with no abnormalities
Drop Comfort Assessment
Time frame: Part 1: 12 days time frame
The comfort of the eye drop will be performed to assess changes from baseline. Drop Comfort Assessment Scale; 0-10; 0 being very comfortable and 10 being very uncomfortable
Intraocular Pressure
Time frame: Part 1: 12 days time frame; Part 2: 35 days time frame
a non-contact tonometer will be used to perform IOP to assess changes from baseline.
Corneal Sensitivity
Time frame: Part 1: 12 days time frame; Part 2: 35 days time frame
The aesthesiometer will be used to perform corneal sensitivity to assess changes from baseline. Corneal Sensitivity Scale. Scale of 0-6
Undilated Fundoscopy
Time frame: Part 2: 35 days time frame
Non-Contact undilated fundoscopy exam will be performed to assess changes from baseline; outcome measure is number of patients with no abnormalities
Vital Signs - Pulse
Time frame: Part 1: 12 days time frame; Part 2: 35 days time frame
Changes in vital signs is performed to assess changes from baseline
Vital Signs - O2 Saturation
Time frame: Part 1: 12 days time frame; Part 2: 35 days time frame
Changes in vital signs is performed to assess changes from baseline
Vital Signs - Systolic Blood Pressure
Time frame: Part 1: 12 days time frame; Part 2: 35 days time frame
Changes in vital signs is performed to assess changes from baseline
Vital Signs - Diastolic Blood Pressure
Time frame: Part 1: 12 days time frame; Part 2: 35 days time frame
Changes in vital signs is performed to assess changes from baseline

6 secondary outcomes

Ocular Discomfort
Time frame: Part 2: 35 days time frame
Dry Eye Symptoms
Time frame: Part 2: 35 days time frame
Dry Eye Signs
Time frame: Part 2: 35 days time frame
Tear Film Break up Time
Time frame: Part 2: 35 days time frame
Schirmer's Test
Time frame: Part 2: 35 days time frame
Daily Symptom Assessment
Time frame: Assessed daily between visit 3b (day 27) to visit 4b (day 35)

Results and safety

Results posted to the registry on 14 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active	37	36
Placebo	32	32

Primary outcome: Visual Acuity

Time frame: Part 1: 12 days time frame; Part 2: 35 days time frame. Mean (Standard Deviation). Unit: logMAR

Measure	Active n = 37	Placebo n = 32
Part 1	0.05 (0.143)	-0.09 (0.156)
Part 2	0.017 (0.1163)	0.075 (0.1242)

Population analysed: Number analyzed represents the sum of numbers analyzed Part 1 and Part 2

Primary outcome: Slit-lamp Biomicroscopy

Time frame: Part 1: 12 days time frame; Part 2: 35 days time frame. Number. Unit: participants

Measure	Active n = 37	Placebo n = 32
Part 1	6	2
Part 2	31	30

Primary outcome: Drop Comfort Assessment

Time frame: Part 1: 12 days time frame. Mean (Standard Deviation). Unit: score on a scale

Measure	Active n = 6	Placebo n = 2
Value	0.71 (0.846)	1.38 (0.495)

Primary outcome: Intraocular Pressure

Time frame: Part 1: 12 days time frame; Part 2: 35 days time frame. Mean (Standard Deviation). Unit: unit of measure "mmHg"

Measure	Active n = 37	Placebo n = 32
Part 1	12.3 (1.03)	15.5 (0.71)
Part 2	12.4 (1.75)	12.8 (2.54)

Population analysed: Number analyzed comes from Part 1 and Part 2

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active	0 of 37 (0%)	6 of 37 (16.2%)	0 of 37
Placebo	0 of 32 (0%)	4 of 32 (12.5%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

G Torkildsen, MD principal investigator

Andover Eye Associates

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TOP1630 Ophthalmic Solution in people with Dry Eye Syndrome, run by ORA, Inc. at 1 site 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 12 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 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 14 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Visual Acuity (time frame: Part 1: 12 days time frame; Part 2: 35 days time frame). The study lists 10 primary outcomes in all. 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 NCT03088605.

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 14 Feb 2024.