A Phase 2 interventional study of NOV03 and Placebo in Dry Eye Disease (DED), sponsored by Novaliq GmbH. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-04.
Sponsored by Novaliq GmbH · Phase 2, Interventional, and Treatment
Among 13 studies testing perfluorohexyloctane in Dry Eye Syndromes — 1 open to participants now, 2 under way, none of them phase 3. perfluorohexyloctane · Dry Eye Syndromes.
Among the 13 studies testing perfluorohexyloctane in Dry Eye Syndromes, this one is the 4th largest by enrollment, is the only one that started in 2018, is one of 2 in phase 2, and was the 1st registered.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 336 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →1 of the 13 studies testing perfluorohexyloctane in Dry Eye Syndromes is open now, in 1 country. Each count lists the studies.
perfluorohexyloctane: first FDA approval 2023 (MIEBO). What it is approved for, and how studies give it, is on its page →
Of the 116 Dry Eye Syndromes studies recruiting now, 73 (63%) set no upper age limit and 24 (21%) stop at 75 or younger; 7 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 1 started in 2018.
Median enrollment 216 across the 13 interventional studies. Of the 10 that completed or were terminated, 6 (60%) have results posted.
10 of 13 have an industry lead sponsor. The 5 most frequent:
Novaliq GmbH is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
11 studies in Dry Eye Syndromes by Novaliq GmbH: none open now, none under way, none of them phase 3. Of 11 finished, 6 (55%) have results posted.
Among the 11 studies in Dry Eye Syndromes by Novaliq GmbH, this one is the only one that started in 2018, is one of 2 in phase 2, and was the 7th registered.
Novaliq GmbH’s Dry Eye Syndromes studies by the year they started, since 2013.
1 of the studies testing perfluorohexyloctane in Dry Eye Syndromes that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07679685Beijing Tongren HospitalPerfluorohexyloctane Eye Drops vs. Sodium Hyaluronate for Video Display Terminal-Associated Dry Eye | 2027-02-28 |
Among the 13 studies testing perfluorohexyloctane in Dry Eye Syndromes, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Novaliq GmbH’s 11 in Dry Eye Syndromes:
Nothing recorded among them since 2026-09-25.
This study will evaluate the efficacy, safety and tolerability of perfluorohexyloctane (NOV03) at two different dosing regimens compared to saline solution in subjects with Dry Eye Disease (DED).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Perfluorohexyloctance solution 4 times daily (QID)
Drug: NOV03
Perfluorohexyloctance solution 2 times daily (BID)
Drug: NOV03
Saline solution (0.9% sodium chloride solution) 4 times daily (QID)
Drug: Placebo
Saline solution (0.9% sodium chloride solution) 2 times daily (BID)
Drug: Placebo
Perfluorohexyloctane
Saline solution (0.9% sodium chloride solution)
Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading)
The primary efficacy variable was comparison of absolute and change from baseline between treatments for total Corneal Fluorescein Staining (tCFS) according to the National Eye Institute grading (NEI Scale) at week 8 The NEI Scale is a standardized grading system. 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.
Time frame: baseline and 2 months
| Milestone | NOV03 2 Times Daily (BID) | NOV03 4 Times Daily (QID) | Placebo BID/QID |
|---|---|---|---|
| Started | 111 | 114 | 111 |
| Completed | 105 | 110 | 108 |
| Not completed | 6 | 4 | 3 |
The primary efficacy variable was comparison of absolute and change from baseline between treatments for total Corneal Fluorescein Staining (tCFS) according to the National Eye Institute grading (NEI Scale) at week 8 The NEI Scale is a standardized grading system. 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.
| score on a scale | NOV03 2 Times Daily (BID) | NOV03 4 Times Daily (QID) | Placebo BID/QID |
|---|---|---|---|
| Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading) | -1.78 (-2.27 to -1.30) | -2.11 (-2.59 to -1.63) | -0.93 (-1.41 to -0.45) |
Collected over whole study duration (8 weeks per patient). Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NOV03 2 Times Daily (BID) | 0/111 (0%) | 1/111 (0.9%) | 1/111 (0.9%) |
| NOV03 4 Times Daily (QID) | 0/114 (0%) | 3/114 (2.6%) | 4/114 (3.5%) |
| Placebo BID/QID | 0/111 (0%) | 0/111 (0%) | 3/111 (2.7%) |
| Event | NOV03 2 Times Daily (BID) | NOV03 4 Times Daily (QID) | Placebo BID/QID |
|---|---|---|---|
| Chest painGeneral disorders | 1/111 | 0/114 | 0/111 |
| DiverticulumGastrointestinal disorders | 0/111 | 1/114 | 0/111 |
| Endometrial adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/111 | 1/114 | 0/111 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/111 | 1/114 | 0/111 |
| Event | NOV03 2 Times Daily (BID) | NOV03 4 Times Daily (QID) | Placebo BID/QID |
|---|---|---|---|
| Instillation site irritationGeneral disorders | 0/111 | 0/114 | 2/111 |
| Vision blurredEye disorders | 0/111 | 2/114 | 1/111 |
| Instillation site painGeneral disorders | 1/111 | 2/114 | 0/111 |
| Age, Continuous(years) | NOV03 2 Times Daily (BID) | NOV03 4 Times Daily (QID) | Placebo BID/QID | Total |
|---|---|---|---|---|
| Mean | 54.0 (22 to 86) | 53.0 (22 to 86) | 53.8 (19 to 85) | 53.6 (19 to 86) |
| Sex: Female, Male(Participants) | NOV03 2 Times Daily (BID) | NOV03 4 Times Daily (QID) | Placebo BID/QID | Total |
|---|---|---|---|---|
| Female | 84 | 79 | 80 | 243 |
| Male | 27 | 35 | 31 | 93 |
| Ethnicity (NIH/OMB)(Participants) | NOV03 2 Times Daily (BID) | NOV03 4 Times Daily (QID) | Placebo BID/QID | Total |
|---|---|---|---|---|
| Hispanic or Latino | 26 | 30 | 21 | 77 |
| Not Hispanic or Latino | 85 | 84 | 90 | 259 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | NOV03 2 Times Daily (BID) | NOV03 4 Times Daily (QID) | Placebo BID/QID | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 | 2 |
| Asian | 20 | 18 | 21 | 59 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 0 | 2 |
| Black or African American | 13 | 13 | 8 | 34 |
| White | 78 | 80 | 81 | 239 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | NOV03 2 Times Daily (BID) | NOV03 4 Times Daily (QID) | Placebo BID/QID | Total |
|---|---|---|---|---|
| United States | 111 | 114 | 111 | 336 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in May 2018, 4 months.
Results were first posted in May 2021, 3 years after primary completion. A results delay was requested in Jun 2019.
Of 75 industry-sponsored phase 2 interventional studies under Dry Eye Syndromes, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 11. This study's 4 months is below that.
Counting every sponsor, half of 91 studies reached it within 7 months; a quarter within 5 and three quarters within 12.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Perfluorohexyloctane
Novaliq GmbH