CompletedPhase 2

Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT.

United States33 participantsStarted 2019-10-17

Plain-language summary

To evaluate the safety and efficacy of Pro-ocular™ 1% topical gel administered twice daily for 70 days in reducing or eliminating symptoms and signs of chronic ocular GvHD.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female of any race, at least 18 years of age at Visit 1 Screening.
. Has the diagnosis of chronic ocular GvHD.
. Has an NIH Consensus Eye Score of at least 2.
. On the GLIA Ocular Surface Disease Symptoms Questionnaire at Screening, has ocular discomfort at a severity score of moderate or more, and at least one other symptom at a severity of moderate or more.
. One or more signs from the list of chronic ocular GvHD signs below
. Has provided verbal and written informed consent.
. Be able and willing to follow oral and written instructions, including participation in all study assessments and visits.

Exclusion criteria

. Wearing scleral or contact lenses within the last month, or those who plan to start wearing scleral or contact lenses during the study.
. Anticipate major changes in systemic GvHD management during study period.
. 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 retinal detachment, recent ocular surgery, Bell's palsy, active trigeminal neuritis or trigeminal neuralgia.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Modified SANDE Questionnaire - Frequency, Change From Baseline

Timeframe: 2 weeks

Corneal Fluorescein Stain - Central, Change From Baseline

Timeframe: 2 weeks

Trial details

NCT IDNCT03990051

SponsorGlia, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-31

Results submitted2024-10-15

View on ClinicalTrials.gov More Chronic Ocular Graft-versus-host Disease trials