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Phase 2 Completed N=129 Randomized Quadruple-blind Treatment

Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction

Posterior Blepharitis · Meibomian Gland Dysfunction
Source: ClinicalTrials.gov NCT04469998 ↗
Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Adverse Events — 1; 1; 2; 0 adverse events

Summary

This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating posterior blepharitis associated with Meibomian Gland Disease (MGD)

Outcome Measures

OutcomeResultp-value
PRIMARY
Adverse Events
1; 1; 2; 0; 0; 0
SECONDARY
Total Meibomian Gland Dysfunction Score
-0.9; -1.7; -2.1

Eligibility Criteria

Inclusion Criteria

Male or female, 18 years or older

Have a clinical diagnosis of moderate to severe MGD (total MGD score between 5 and 14 on a scale with a range between 0 and 15; and clinical severity score of eyelid margin vascularity of at least 2 (moderate))

Have a score of ≥35 on Eye Discomfort using VAS

Have a tFCS score between 3 and 14 on the NEI scale

Have a Schirmer score of >7 mm

Have a OSDI score >30

If female, then subject should be non-pregnant and non-lactating

Exclusion Criteria

Subjects with iritis, uveitis in either eye

Subjects with conjunctivitis, keratitis, severe anterior keratitis not related to MGD

Subjects with lid abnormalities

Subjects with ocular fungal, viral or bacterial infection

Subjects unable or unwilling to withhold the use of eyelid scrubs

Subjects with glaucoma and serious systemic disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04469998). 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.

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