N/A
N=32
Optive Brand For Day And Night Dry Eye Management
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT03208673 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score — -12.85 Scores on a scale — p=.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Optive® Fusion + Optive® Gel Drop (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score |
-12.85 | .001 sig |
| PRIMARY Measured Lissamine Green Bulbar Conjunctival Staining (mm2) |
0.03; 0.03 | 0.025 sig |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking |
30.22; 58.02; 59.08; 42.28; 52.95; 31.09 | <0.001 sig |
Summary
This is an open label study of Optive eyedrops and gel combination for day and night dry eye management
Eligibility Criteria
Inclusion Criteria
- OSDI score of ≥ 23
- Ocular comfort at waking <65 on 100-point scale
- Conjunctival staining Grade ≥ 2 (scale 0 to 4) in at least one eye
- Use of eyedrops for the relief of dry eye symptoms for at least one month
- Best corrected visual acuity in each eye of at least 20/25
- Have normal eyes with the exception of the need for visual correction; subjects must be willing to cease contact lens wear for the duration of the study
- Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
Exclusion Criteria
- Use of Benzalkonium Chloride (BAK) preserved eyedrops in the last month
- Use of Optive brand eyedrops in the last month
- Monocular participants (only one eye with functional vision).
- Contact lens wear during the study
- History of herpetic keratitis, ocular surgery or irregular cornea;
- Known pregnancy or lactation during the study period
- Participation in any clinical trial within 30 days of the enrollment visit
Data sourced from ClinicalTrials.gov (NCT03208673). 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.