Dry EyePhase 2NCT04510428
OSIG-eye Drops Treatment for Dry Eye Disease
A Phase 2 study testing Ocular Surface Immune Globulin (OSIG) in people with Dry Eye, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The main objective of this study is to assess the clinical and mechanistic effect of using Ocular surface immunoglobulin (OSIG) eye drops for treating Dry Eye Disease. Therefore, the investigator will perform a prospective, phase II, randomized, placebo-controlled, double-masked, tolerability and efficacy clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Ocular Surface Immune Globulin (OSIG)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 20 Jan 2024
- 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
- Able to Sign and date the informed consent form approved by the Institutional Review Board (IRB)
- ≥ 18 years of age
- Patient reported dry eye-related ocular symptoms for at least 3 months before the Screening Visit and use or desire to use artificial tears, ointments or dry eye treatments in the 2 weeks preceding the screening visit
- Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 14 days of receiving her first dose of test medication (placebo/ study drug) along with definite evidence of contraceptive use during the duration of the study. Women of reproductive age should use a method of birth control that is acceptable to the subject and the study doctor. This may include oral contraceptive pills, birth control implants, barrier methods or abstinence. If a subject mentions she suspects she may be pregnant after being enrolled, another pregnancy test will be administered. If the test is positive, she will be discontinued from the study immediately.
- Be willing/able to return for all study visits and to follow instructions from the study investigator and his staff
Who cannot join
- Inability to provide informed consent.
- Vulnerable populations, such as neonates, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.
- Contact lens wear within two weeks of baseline visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Illinois Eye and Ear Infirmary, University of Illinois
Chicago, Illinois, 60612
About this study
Official title: A Phase II Randomized Placebo-Controlled, Double Blind, Single-Center, Tolerability and Efficacy Clinical Trial of Ocular Surface Immunoglobulin (OSIG) Eye Drops In Patients With Dry Eye Disease
The main objective of this study is to assess the clinical and mechanistic effect of using Ocular surface immunoglobulin (OSIG) eye drops for treating Dry Eye Disease. Therefore, the investigator will perform a prospective, phase II, randomized, placebo-controlled, double-masked, tolerability and efficacy clinical trial using OSIG-eye drops in patients with Dry Eye Disease. This clinical trial will be powered to detect efficacy of the treatment.
This will be a Randomized controlled trial, in which a total of 40 subjects will be enrolled at one clinical site. Subjects will be randomly assigned to one of two groups (#1, #2), with 20 subjects per group. One group will be given placebo (Normal saline eye drops) and the other group will be given eye drops containing the study drug (OSIG). Treatment will be for eight weeks.
- Conditions
- Dry Eye
- Being tested
- Ocular Surface Immune Globulin (OSIG), Placebo
- 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.
Ocular Surface Immune Globulin (OSIG)Drug
Ocular Surface Immune Globulin (OSIG) eye drops 4 mg/ml (0.4%) four times a day for 8 weeks
PlaceboDrug
Normal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| OSIG-Eye Drop | Experimental | Ocular Surface Immune Globulin (OSIG) eye drops 4 mg/ml (0.4%) four times a day for 8 weeks Receives: Drug: Ocular Surface Immune Globulin (OSIG) |
| Placebo-Eye Drop | Placebo comparator | Normal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean reduction in Epitheliopathy at week 8, compared to day 1 (pre-dose), as measured by corneal staining score using National Eye Institute (NEI) grading scale.
Corneal staining score as measured by Lissamine Green dye staining using National Eye Institute (NEI) grading scale. Dye is applied to each eye and a slit lamp is used to observe corneal staining. NEI scale relies on a chart that divides the cornea into 5 sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the density of punctate staining, final staining score being the sum of individual section scores with a range of 0 (minimum) -15 (maximum) points. Complete corneal staining clearance with Lissamine dye defined as a score of 0 indicating the best outcome.
Measured: 8 Weeks
Mean reduction in Dry Eye Disease (DED) symptoms as measured by the Ocular surface disease index (OSDI) score at 8 week, compared to day 1 (pre-dose)
Ocular Surface Disease Index (OSDI), a 12-item questionnaire, assesses symptom of ocular irritation in dry eye disease (DED) and how it affects functioning related to vision in the past week. It has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on 0 to 4 scale with 0 being "none of the time" and 4 being "all of the time." OSDI score range from 0-100 with score 0-12 being normal, 13-22 being mild DED, 23-32 being moderate DED, and >33 being severe DED. OSDI=[(sum of scores for questions answered)×100]/[(total questions answered)×4]
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start15 May 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion20 Jan 2024 (estimated)
Why it stopped: Study not initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandeep Jain, MD, University of Illinois Chicago
- Investigators
- Sandeep Jain, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510428
- Sponsor's protocol ID
- 2020-0925
- Status last verified
- May 2023
- First submitted
- 6 Aug 2020
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- 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 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Placebo-Controlled, Double Blind, Single-Center, Tolerability and Efficacy Clinical Trial of Ocular Surface Immunoglobulin (OSIG) Eye Drops In Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04510428
- Acronym / sponsor ID
- 2020-0925
- Conditions
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 12 Aug 2020 (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 main objective of this study is to assess the clinical and mechanistic effect of using Ocular surface immunoglobulin (OSIG) eye drops for treating Dry Eye Disease. Therefore, the investigator will perform a prospective, phase II, randomized, placebo-controlled, double-masked, tolerability and efficacy clinical trial using OSIG-eye drops in patients with Dry Eye Disease. This clinical trial will be powered to detect efficacy of the treatment.
This will be a Randomized controlled trial, in which a total of 40 subjects will be enrolled at one clinical site. Subjects will be randomly assigned to one of two groups (#1, #2), with 20 subjects per group. One group will be given placebo (Normal saline eye drops) and the other group will be given eye drops containing the study drug (OSIG). Treatment will be for eight weeks.
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 |
|---|---|---|
| OSIG-Eye Drop | Experimental | Drug: Ocular Surface Immune Globulin (OSIG)Ocular Surface Immune Globulin (OSIG) eye drops 4 mg/ml (0.4%) four times a day for 8 weeks |
| Placebo-Eye Drop | Placebo comparator | Drug: PlaceboNormal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to Sign and date the informed consent form approved by the Institutional Review Board (IRB)
- ≥ 18 years of age
- Patient reported dry eye-related ocular symptoms for at least 3 months before the Screening Visit and use or desire to use artificial tears, ointments or dry eye treatments in the 2 weeks preceding the screening visit
- Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 14 days of receiving her first dose of test medication (placebo/ study drug) along with definite evidence of contraceptive use during the duration of the study. Women of reproductive age should use a method of birth control that is acceptable to the subject and the study doctor. This may include oral contraceptive pills, birth control implants, barrier methods or abstinence. If a subject mentions she suspects she may be pregnant after being enrolled, another pregnancy test will be administered. If the test is positive, she will be discontinued from the study immediately.
- Be willing/able to return for all study visits and to follow instructions from the study investigator and his staff
Key exclusion criteria (3 listed)
- Inability to provide informed consent.
- Vulnerable populations, such as neonates, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.
- Contact lens wear within two weeks of baseline visit.
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 |
|---|---|---|
| Ocular Surface Immune Globulin (OSIG)Ocular Surface Immune Globulin (OSIG) eye drops 4 mg/ml (0.4%) four times a day for 8 weeks | Drug | OSIG-Eye Drop |
| PlaceboNormal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks | Drug | Placebo-Eye Drop |
Primary outcome
Mean reduction in Epitheliopathy at week 8, compared to day 1 (pre-dose), as measured by corneal staining score using National Eye Institute (NEI) grading scale.
Time frame: 8 Weeks
Corneal staining score as measured by Lissamine Green dye staining using National Eye Institute (NEI) grading scale. Dye is applied to each eye and a slit lamp is used to observe corneal staining. NEI scale relies on a chart that divides the cornea into 5 sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the density of punctate staining, final staining score being the sum of individual section scores with a range of 0 (minimum) -15 (maximum) points. Complete corneal staining clearance with Lissamine dye defined as a score of 0 indicating the best outcome.
Mean reduction in Dry Eye Disease (DED) symptoms as measured by the Ocular surface disease index (OSDI) score at 8 week, compared to day 1 (pre-dose)
Time frame: 8 Weeks
Ocular Surface Disease Index (OSDI), a 12-item questionnaire, assesses symptom of ocular irritation in dry eye disease (DED) and how it affects functioning related to vision in the past week. It has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on 0 to 4 scale with 0 being "none of the time" and 4 being "all of the time." OSDI score range from 0-100 with score 0-12 being normal, 13-22 being mild DED, 23-32 being moderate DED, and >33 being severe DED. OSDI=[(sum of scores for questions answered)×100]/[(total questions answered)×4]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- 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.
Sandeep Jain, MD principal investigator
University of Illinois Chicago
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 Ocular Surface Immune Globulin (OSIG) in people with Dry Eye, run by University of Illinois Chicago 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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 23 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean reduction in Epitheliopathy at week 8, compared to day 1 (pre-dose), as measured by corneal staining score using National Eye Institute (NEI) grading scale. (time frame: 8 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 23 May 2023.