Phase 3
Completed N=183
Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye
Source: ClinicalTrials.gov NCT01657253 ↗Enrolled (actual)
183
Serious AEs
0.5%
Results posted
Dec 2017
Primary outcomePrimary: Ocular Surface Disease Index (OSDI©) Questionnaire — 19.3; 19.3; 7.3; 7.9 points
◆ Published Evidence
Established
25citations · ~3 / year
Efficacy of a fixed combination of 0.09 % xanthan gum/0.1 % chondroitin sulfate preservative free vs polyethylene glycol/propylene glycol in subjects with dry eye disease: a multicenter randomized controlled trial.
Summary
The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®
Linked Publications
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Efficacy of a fixed combination of 0.09 % xanthan gum/0.1 % chondroitin sulfate preservative free vs polyethylene glycol/propylene glycol in subjects with dry eye disease: a multicenter randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Surface Disease Index (OSDI©) Questionnaire |
19.3; 19.3; 7.3; 7.9 | — |
| SECONDARY Schirmer Test |
6.4; 6.5; 11.0; 10.5 | — |
| SECONDARY Tear Film Break up Time |
5.5; 5.2; 7.4; 7.4 | — |
Eligibility Criteria
Inclusion Criteria
- Mild to moderate dry eye patients based on the Report of International Dry Eye Workshop (DEWS)
- OSDI score between 12 and 45
- Provided informed consent
Exclusion Criteria
- Patients with one blind eye
- Visual acuity of 20/100 or worst in any eye
- Patients with any active ocular disease that would interfere with study interpretation
- Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol
- Patients with history of hypersensitivity or contraindication for any drug used in the study
- Contact lens users
- Pregnant patients, at risk of pregnancy or breastfeeding
- Patients without birth control treatment
- Patients who had participated in any clinical trial in the last 90 days
- Legal or mentally disabled patients who could not give informed consent
- Patients who do not provide informed consent
Data sourced from ClinicalTrials.gov (NCT01657253) 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.