Phase 3
Completed N=597
Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
Dry Eye Disease (DED)
Source: ClinicalTrials.gov NCT04139798 ↗
Enrolled (actual)
597
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57 — -2.0; -1.0 units on a scale
◆ Published Evidence
Emerging
12citations · ~4 / year
Novel Treatments for Chronic Ocular Surface Pain.
Summary
This trial will evaluate the efficacy, safety, and tolerability of NOV03 ophthalmic solution in comparison to a saline control for the treatment of the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD).
Linked Publications (2)
-
Novel Treatments for Chronic Ocular Surface Pain.
-
Perfluorohexyloctane ophthalmic solution for dry eye disease: pooled analysis of two phase 3 clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57 |
-2.0; -1.0 | — |
| PRIMARY Change From Baseline of Dryness Score at Day 57 |
-27.4; -19.7 | — |
Eligibility Criteria
Inclusion Criteria
- Signed ICF (Informed Consent Form)
- Subject-reported history of Drye Eye Disease (DED) in both eyes
- Ability and willingness to follow instructions, including participation in all study assessments and visits
Exclusion Criteria
- Women who are pregnant, nursing or planning pregnancy
- Unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
- Clinically significant slit-lamp findings or abnormal lid anatomy at screening and Visit 1
- Ocular/peri-ocular malignancy
- History of herpetic keratitis
- Active ocular allergies or ocular allergies that are expected to be active during the study
- Ongoing ocular or systemic infection
- Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study
- Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period
- Presence of uncontrolled systemic diseases
- Presence of known allergy and/or sensitivity to the study drug or saline components
- Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening
Data sourced from ClinicalTrials.gov (NCT04139798) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.