Dry Eye SyndromePhase 2NCT04884217
Treatment of Dry Eye Disease Using Pro-ocular™ - A Proof of Concept, Safety, and Efficacy Study
A Phase 2 study testing Pro-ocular™ Topical Gel in people with Dry Eye Syndrome and Keratoconjunctivitis Sicca, run by PharmaDax Inc. at 1 site in Taiwan.
Trial summary
To evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks in treatment of Dry Eye Disease Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye Syndrome, Keratoconjunctivitis Sicca
- What is being tested?
- Pro-ocular™ Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 May 2021to 30 Dec 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of any race, at least 20 years of age at Visit 1 Screening.
- Has a subject reported history (including physician diagnosis) of dry eye disease in both eyes for at least 3 months prior to Visit 1.
- Has SANDE score ≥50 in either frequency or severity of symptoms of dryness and/or irritation at Visit 1.
- Have all of the following in the same eye at Visit 1:
- Fluorescein Tear Break-Up Time of ≤5 seconds.
- Corneal fluorescein staining score of moderate or more in any field (inferior, superior or central).
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- Report a severity score of moderate or more on ocular dryness and at least one of the other symptoms on the GLIA Ocular Surface Disease Symptoms Questionnaire.
- Has provided written informed consent.
- Be able and willing to follow oral and written instructions, including participation in all study assessments and visits.
Who cannot join
- Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as but not limited to corneal opacities and scars, dystrophies, epithelial scarring, infections, history of blood clots, etc.
- Has infections, or inflammatory skin lesion in or around the dosing area.
- Best corrected visual acuity baseline <20/200.
- Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study.
- Wear contact lens within 7 days prior to Visit 1.
- Anticipate change of vision correction or anticipate any ocular procedures during study period.
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- A woman who is pregnant or testing positive in the blood pregnancy test at screening, nursing an infant, or planning a pregnancy.
- Has a known adverse reaction and/or sensitivity to the study drug or its components.
- Use of topical ocular cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), diquafosol (Diquas®), eye gels, eye ointments, any administration route of steroids, anti-histamines, antipsychotics, antidepressants and NSAIDs within 30 days prior to Visit 1.
- Routine use (more than once a week) of a chlorinated swimming pool during study period.
- Unwilling or unable to cease using the following medications during the study period (from Visit 1 to Visit 6): Topical ocular cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), diquafosol (Diquas®), eye gels, eye ointments, any administration route of steroids, anti-histamines, antipsychotics, antidepressants and NSAIDs..
- Unwilling to cease the use of sunscreen and face scrubs on the forehead or eye area during study period.
- Smoke within 3 months prior to Visit 1.
- Ongoing glaucoma treatment within 30 days prior to Visit 1 and during study period.
- Currently enrolled in an investigational drug or device study within 30 days prior to Visit 1 and during study period.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Tri-Service General Hospital, National Defense Medical Center
Taipei, 11490
About this study
To evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks in treatment of Dry Eye Disease
Read the detailed description
Pro-ocular™ 1% topical gel his demonstrated efficacy in rapidly reducing or eliminating dry eye symptoms, and after multiple doses, the signs and symptoms of ocular surface disease including dry eye disease.
Study DE-2 is single center, randomized, double-masked, placebo-controlled, parallel-group study designed to evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks for treatment of Dry Eye Disease. The approximately 80 subjects will be randomized 1:1, active drug:placebo.
- Conditions
- Dry Eye Syndrome, Keratoconjunctivitis Sicca
- Being tested
- Pro-ocular™ Topical Gel, Placebo Topical Gel
- Keywords
- Dry Eye, Dry Eye Disease, Evaporative Dry Eye, Evaporative Dry Eye Disease, Keratoconjuncitivitis Sicca, Sjogren's Sydrome
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-ocular™ Topical GelDrug
Also called PG101
Pro-ocular™ Topical Gel 1% is applied dermally to the forehead twice-daily
Placebo Topical GelDrug
Placebo is a toopical gel without active ingredient applied dermally to the forehead twice-daily
| Study group | Role | What they receive |
|---|---|---|
| Pro-ocular™ | Active comparator | Pro-ocular™ Topical Gel Receives: Drug: Pro-ocular™ Topical Gel |
| Placebo | Placebo comparator | Placebo Topical Gel Receives: Drug: Placebo Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score
Change from baseline in SANDE symptoms frequency score (0-100 worst)
Measured: 2 weeks
Change in corneal (central) fluorescein staining score
Change from baseline in score on a visual analog scale (0-10 worst)
Measured: 4 weeks
Secondary outcomes (77)
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score
Change from baseline in SANDE symptoms global score (0-100 worst)
Measured: 2 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score
Change from baseline in SANDE symptoms global score (0-100 worst)
Measured: 4 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score
Change from baseline in SANDE symptoms global score (0-100 worst)
Measured: 8 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score
Change from baseline in SANDE symptoms global score (0-100 worst)
Measured: 12 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score
Change from baseline in SANDE symptoms frequency score (0-100 worst)
Measured: 4 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score
Change from baseline in SANDE symptoms frequency score (0-100 worst)
Measured: 8 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score
Change from baseline in SANDE symptoms frequency score (0-100 worst)
Measured: 12 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score
Change from baseline in SANDE symptoms severity score (0-100 worst)
Measured: 2 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score
Change from baseline in SANDE symptoms severity score (0-100 worst)
Measured: 4 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score
Change from baseline in SANDE symptoms severity score (0-100 worst)
Measured: 8 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score
Change from baseline in SANDE symptoms severity score (0-100 worst)
Measured: 12 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)
Measured: 1 hour
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)
Measured: 2 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)
Measured: 4 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)
Measured: 8 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)
Measured: 12 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
Change from baseline in GLIA OSDSQ sum of scores (highest worst)
Measured: 1 hour
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
Change from baseline in GLIA OSDSQ sum of scores (highest worst)
Measured: 2 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
Change from baseline in GLIA OSDSQ sum of scores (highest worst)
Measured: 4 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
Change from baseline in GLIA OSDSQ sum of scores (highest worst)
Measured: 8 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
Change from baseline in GLIA OSDSQ sum of scores (highest worst)
Measured: 12 weeks
Change in Tear Film Grading by TearScan examination
Change from baseline in tear film grade (0-3 best)
Measured: 1 hour
Change in Tear Film Grading by TearScan examination
Change from baseline in tear film grade (0-3 best)
Measured: 2 weeks
Change in Tear Film Grading by TearScan examination
Change from baseline in tear film grade (0-3 best)
Measured: 4 weeks
Change in Tear Film Grading by TearScan examination
Change from baseline in tear film grade (0-3 best)
Measured: 8 weeks
Change in Tear Film Grading by TearScan examination
Change from baseline in tear film grade (0-3 best)
Measured: 12 weeks
Change in Meibography score by Keratograph®
Change from baseline using Grades 0 to 3 (0 no loss to 3 >2/3 loss)
Measured: 12 weeks
Change in Tear Meniscus Height (TMH) by Keratograph®
Change from baseline in mm TMH (higher is better)
Measured: 1 hour
Change in Tear Meniscus Height (TMH) by Keratograph®
Change from baseline in mm TMH (higher is better)
Measured: 4 weeks
Change in Tear Meniscus Height (TMH) by Keratograph®
Change from baseline in mm TMH (higher is better)
Measured: 8 weeks
Change in Tear Meniscus Height (TMH) by Keratograph®
Change from baseline in mm TMH (higher is better)
Measured: 12 weeks
Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)
Change from baseline in NIKBUT in seconds (longer is better)
Measured: 1 hour
Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)
Change from baseline in NIKBUT in seconds (longer is better)
Measured: 4 weeks
Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)
Change from baseline in NIKBUT in seconds (longer is better)
Measured: 8 weeks
Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)
Change from baseline in NIKBUT in seconds (longer is better)
Measured: 12 weeks
Change in Bulbar redness score by Keratograph®
Change from baseline in Bulbar redness score (highest is worst)
Measured: 1 hour
Change in Bulbar redness score by Keratograph®
Change from baseline in Bulbar redness score (highest is worst)
Measured: 4 weeks
Change in Bulbar redness score by Keratograph®
Change from baseline in Bulbar redness score (highest is worst)
Measured: 8 weeks
Change in Bulbar redness score by Keratograph®
Change from baseline in Bulbar redness score (highest is worst)
Measured: 12 weeks
Change in tear film osmolarity by TearLab™ osmolarity system
Change from baseline in mOsms/L (higher value is worse)
Measured: 1 hour
Change in tear film osmolarity by TearLab™ osmolarity system
Change from baseline in mOsms/L (higher value is less sensitive)
Measured: 2 weeks
Change in corneal sensitivity using Cochet-Bonnet esthesiometer
Change from baseline in mm Hg (higher is less sensitive)
Measured: 1 hour
Change in corneal sensitivity using Cochet-Bonnet esthesiometer
Change from baseline in mm Hg (higher is less sensitive)
Measured: 2 weeks
Change in corneal sensitivity using Cochet-Bonnet esthesiometer
Change from baseline in mm Hg (higher is less sensitive)
Measured: 4 weeks
Change in corneal sensitivity using Cochet-Bonnet esthesiometer
Change from baseline in mm Hg (higher is less sensitive)
Measured: 8 weeks
Change in corneal sensitivity using Cochet-Bonnet esthesiometer
Change from baseline in mm Hg (higher is less sensitive)
Measured: 12 weeks
Change in Fluorescein Tear Break-Up Time (FBUT)
Change from baseline in FBUT in seconds (longer is better)
Measured: 1 hour
Change in Fluorescein Tear Break-Up Time (FBUT)
Change from baseline in FBUT in seconds (longer is better)
Measured: 4 weeks
Change in Fluorescein Tear Break-Up Time (FBUT)
Change from baseline in FBUT in seconds (longer is better)
Measured: 8 weeks
Change in Fluorescein Tear Break-Up Time (FBUT)
Change from baseline in FBUT in seconds (longer is better)
Measured: 12 weeks
Change in corneal (central) fluorescein staining score
Change from baseline in central corneal fluorescein staining score (0-10 worst)
Measured: 2 weeks
Change in corneal (central) fluorescein staining score
Change from baseline in central corneal fluorescein staining score (0-10 worst)
Measured: 8 weeks
Change in corneal (central) fluorescein staining score
Change from baseline in central corneal fluorescein staining score (0-10 worst)
Measured: 12 weeks
Change in corneal (inferior) fluorescein staining score
Change from baseline in inferior corneal fluorescein staining score (0-10 worst)
Measured: 2 weeks
Change in corneal (inferior) fluorescein staining score
Change from baseline in inferior corneal fluorescein staining score (0-10 worst)
Measured: 4 weeks
Change in corneal (inferior) fluorescein staining score
Change from baseline in inferior corneal fluorescein staining score (0-10 worst)
Measured: 8 weeks
Change in corneal (inferior) fluorescein staining score
Change from baseline in inferior corneal fluorescein staining score (0-10 worst)
Measured: 12 weeks
Change in corneal (superior) fluorescein staining score
Change from baseline in superior corneal fluorescein staining score (0-10 worst)
Measured: 2 weeks
Change in corneal (superior) fluorescein staining score
Change from baseline in superior corneal fluorescein staining score (0-10 worst)
Measured: 4 weeks
Change in corneal (superior) fluorescein staining score
Change from baseline in superior corneal fluorescein staining score (0-10 worst)
Measured: 8 weeks
Change in corneal (superior) fluorescein staining score
Change from baseline in superior corneal fluorescein staining score (0-10 worst)
Measured: 12 weeks
Change in corneal fluorescein staining sum of scores
Change from baseline in corneal fluorescein staining sum of scores (0-30 worst)
Measured: 2 weeks
Change in corneal fluorescein staining sum of scores
Change from baseline in corneal fluorescein staining sum of scores (0-30 worst)
Measured: 4 weeks
Change in corneal fluorescein staining sum of scores
Change from baseline in corneal fluorescein staining sum of scores (0-30 worst)
Measured: 8 weeks
Change in corneal fluorescein staining sum of scores
Change from baseline in corneal fluorescein staining sum of scores (0-30 worst)
Measured: 12 weeks
Change in conjunctival fluorescein staining sum of scores
Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst)
Measured: 2 weeks
Change in conjunctival fluorescein staining sum of scores
Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst)
Measured: 4 weeks
Change in conjunctival fluorescein staining sum of scores
Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst)
Measured: 8 weeks
Change in conjunctival fluorescein staining sum of scores
Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst)
Measured: 12 weeks
Change in lissamine green staining (corneal and conjunctival) sum of scores
Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores
Measured: 2 weeks
Change in lissamine green staining (corneal and conjunctival) sum of scores
Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores (higher is worse)
Measured: 4 weeks
Change in lissamine green staining (corneal and conjunctival) sum of scores
Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores (higher is worse)
Measured: 8 weeks
Change in lissamine green staining (corneal and conjunctival) sum of scores
Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores (higher is worse)
Measured: 12 weeks
Change in conjunctival hyperemia (by slit lamp biomicroscopy)
Change from baseline in conjunctival hyperemia score (0-10 worst)
Measured: 2 weeks
Change in conjunctival hyperemia (by slit lamp biomicroscopy)
Change from baseline in conjunctival hyperemia score (0-10 worst)
Measured: 4 weeks
Change in conjunctival hyperemia (by slit lamp biomicroscopy)
Change from baseline in conjunctival hyperemia score (0-10 worst)
Measured: 8 weeks
Change in conjunctival hyperemia (by slit lamp biomicroscopy)
Change from baseline in conjunctival hyperemia score (0-10 worst)
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 posted12 May 2021
- Study start20 May 2021 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaDax Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glia, LLC
- Responsible party
- Sponsor
- Investigators
- Peichun Kuo, Study director, PharmaDax Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884217
- Sponsor's protocol ID
- DE-2
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Dry Eye Disease Using Pro-ocular™ - A Proof of Concept, Safety, and Efficacy Study
- ClinicalTrials.gov ID
- NCT04884217
- Acronym / sponsor ID
- DE-2
- Conditions
- Dry Eye Syndrome, Keratoconjunctivitis Sicca
- Keywords
- Dry Eye, Dry Eye Disease, Evaporative Dry Eye, Evaporative Dry Eye Disease, Keratoconjuncitivitis Sicca, Sjogren's Sydrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- PharmaDax Inc.Industry (pharma, biotech, devices)
- Collaborators
- Glia, LLC
- Study start
- 20 May 2021 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 12 May 2021 (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.
To evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks in treatment of Dry Eye Disease
Detailed description
Pro-ocular™ 1% topical gel his demonstrated efficacy in rapidly reducing or eliminating dry eye symptoms, and after multiple doses, the signs and symptoms of ocular surface disease including dry eye disease.
Study DE-2 is single center, randomized, double-masked, placebo-controlled, parallel-group study designed to evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks for treatment of Dry Eye Disease. The approximately 80 subjects will be randomized 1:1, active drug:placebo.
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 |
|---|---|---|
| Pro-ocular™ | Active comparator | Drug: Pro-ocular™ Topical GelPro-ocular™ Topical Gel |
| Placebo | Placebo comparator | Drug: Placebo Topical GelPlacebo Topical Gel |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female of any race, at least 20 years of age at Visit 1 Screening.
- Has a subject reported history (including physician diagnosis) of dry eye disease in both eyes for at least 3 months prior to Visit 1.
- Has SANDE score ≥50 in either frequency or severity of symptoms of dryness and/or irritation at Visit 1.
- Have all of the following in the same eye at Visit 1:
- Has provided written informed consent.
Key exclusion criteria (15 listed)
- Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as but not limited to corneal opacities and scars, dystrophies, epithelial scarring, infections, history of blood clots, etc.
- Has infections, or inflammatory skin lesion in or around the dosing area.
- Best corrected visual acuity baseline <20/200.
- Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study.
- Wear contact lens within 7 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 |
|---|---|---|
| Pro-ocular™ Topical GelAlso: PG101Pro-ocular™ Topical Gel 1% is applied dermally to the forehead twice-daily | Drug | Pro-ocular™ |
| Placebo Topical GelPlacebo is a toopical gel without active ingredient applied dermally to the forehead twice-daily | Drug | Placebo |
Primary outcome
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score
Time frame: 2 weeks
Change from baseline in SANDE symptoms frequency score (0-100 worst)
Change in corneal (central) fluorescein staining score
Time frame: 4 weeks
Change from baseline in score on a visual analog scale (0-10 worst)
77 secondary outcomes
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score
Time frame: 2 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score
Time frame: 4 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score
Time frame: 8 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score
Time frame: 12 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score
Time frame: 4 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score
Time frame: 8 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score
Time frame: 12 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score
Time frame: 2 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score
Time frame: 4 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score
Time frame: 8 weeks
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score
Time frame: 12 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
Time frame: 1 hour
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
Time frame: 2 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
Time frame: 4 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
Time frame: 8 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
Time frame: 12 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
Time frame: 1 hour
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
Time frame: 2 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
Time frame: 4 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
Time frame: 8 weeks
Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
Time frame: 12 weeks
Change in Tear Film Grading by TearScan examination
Time frame: 1 hour
Change in Tear Film Grading by TearScan examination
Time frame: 2 weeks
Change in Tear Film Grading by TearScan examination
Time frame: 4 weeks
Change in Tear Film Grading by TearScan examination
Time frame: 8 weeks
Change in Tear Film Grading by TearScan examination
Time frame: 12 weeks
Change in Meibography score by Keratograph®
Time frame: 12 weeks
Change in Tear Meniscus Height (TMH) by Keratograph®
Time frame: 1 hour
Change in Tear Meniscus Height (TMH) by Keratograph®
Time frame: 4 weeks
Change in Tear Meniscus Height (TMH) by Keratograph®
Time frame: 8 weeks
Change in Tear Meniscus Height (TMH) by Keratograph®
Time frame: 12 weeks
Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)
Time frame: 1 hour
Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)
Time frame: 4 weeks
Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)
Time frame: 8 weeks
Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)
Time frame: 12 weeks
Change in Bulbar redness score by Keratograph®
Time frame: 1 hour
Change in Bulbar redness score by Keratograph®
Time frame: 4 weeks
Change in Bulbar redness score by Keratograph®
Time frame: 8 weeks
Change in Bulbar redness score by Keratograph®
Time frame: 12 weeks
Change in tear film osmolarity by TearLab™ osmolarity system
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- 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.
Peichun Kuo study director
PharmaDax Inc.
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 Pro-ocular™ Topical Gel in people with Dry Eye Syndrome and Keratoconjunctivitis Sicca, run by PharmaDax Inc. at 1 site in Taiwan.
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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 14 May 2021. 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 Taiwan. 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?
Results are not available in the source record.
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 in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score (time frame: 2 weeks). 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 14 May 2021.