Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets

Vision Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057966
• Other study ID #: SMA-09-32
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2010
• Last updated: January 31, 2012
• Start date: February 2010
• Est. completion date: September 2011

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is a comparison of the bioavailability of nutrients contained in softgel capsules vs tablets.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 to 35

2. Body Mass Index (BMI) 21-27 kg/m2

3. Must be able to give written informed consent

4. Subjects must be willing to comply with all study requirements.

5. Subjects must understand, sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

1. Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria

2. Subjects who are pregnant, lactating or planning to be pregnant during the course of the study

3. Subjects with known sensitivity to planned study concomitant medications

4. Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.

5. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Vision

Intervention

Dietary Supplement:
• ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength)
Single full strength dose capsule taken one time
• ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength)
Single half strength dose capsule taken one time
• ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength)
Single, full strength dose tablet taken one time

Locations

Country	Name	City	State
United States	Contact Alcon Call Center For Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability of nutrients		1 week for each treatment cross-over period	No