Endothelial Bleb Response With Toric Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Ametropia

Treatments: Device: lotrafilcon B toric; Device: alphafilcon A toric; Device: senofilcon A toric

Study type: Interventional

Funder types: Industry

Identifiers

NCT00630305

CR-0726

JJO0717

Details and patient eligibility

About

Evaluate the short-term corneal response of oxygen deprivation when using toric contact lenses. The response will be noted by endothelial bleb formation in both open eye and closed eye state.

Full description

Interested subjects who meet the entry criteria for the study will be scheduled for four sessions of approximately 30 minutes duration each. Informed consent obtained. Baseline measurements of visual acuity and corneal and conjunctival physiology will be recorded. An examination of the endothelium of the corneas will be conducted using the specular microscope, readings obtained at 5 locations on each cornea: one in the centre and one in each of the superior, inferior, nasal and temporal peripheral regions, approximately 2mm from the limbal margin. The assigned lenses will be inserted according to a fixed-allocation randomization schedule, where each session follows an optimized 2- period simultaneous crossover design, which specifies lenses to be used in each of the four sessions. Lenses will be worn for 20 minutes and then removed. Endothelial specular microscopy will be conducted at 20 minutes with the lenses on. A final evaluation of corneal and conjunctival physiology will be performed prior to subject clearance from the study.

Enrollment: 37 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Successful soft contact lens wear in daily mode for a minimum of 1 month prior to start of the study without experiencing difficulties or contact lens related complications.
2. At least 18 years of age and mentally competent to sign an informed consent form.
3. Healthy eyes and no use of ocular medication.
4. Similarity of optical parameters between eyes.
5. Physical appearance typical of Asian eyes

Exclusion criteria

1. A medical or ocular condition that may influence the outcome of this trial.
2. Current use of ocular/systemic medication that may influence the outcome of this trial.
3. Failure to wear soft lenses for 2 weeks prior to the start of the study.
4. Current enrolment or participation in another clinical study.
5. Current state of pregnancy or breastfeeding
6. Anisometropia greater than 1.00D (equivalent sphere).
7. Unequal acuities between eyes (greater than 1 line)
8. Unequal corneal curvatures (>1.00D)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

37 participants in 4 patient groups

Session A

Other group

Description:

Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session A only contains senofilcon A toric and alphafilcon A toric lenses.

Treatment:

Device: senofilcon A toric

Device: alphafilcon A toric

Session B

Other group

Description:

Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session B only contains senofilcon A toric and alphafilcon A toric lenses.

Treatment:

Device: senofilcon A toric

Device: alphafilcon A toric

Session C

Other group

Description:

Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session C only contains senofilcon A toric and lotrafilcon B toric lenses.

Treatment:

Device: lotrafilcon B toric

Device: senofilcon A toric

Session D

Other group

Description:

Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session D only contains senofilcon A toric and lotrafilcon B toric lenses.

Treatment:

Device: lotrafilcon B toric

Device: senofilcon A toric